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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01958281
Registration number
NCT01958281
Ethics application status
Date submitted
6/10/2013
Date registered
9/10/2013
Date last updated
8/08/2018
Titles & IDs
Public title
Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency
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Scientific title
A Phase 2b, Open-Label Study of 200 mg or 400 mg Sofosbuvir+RBV for 24 Weeks in Genotype 1 or 3 and Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 Weeks in Genotype 1 or 4 HCV Infected Subjects With Renal Insufficiency
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Secondary ID [1]
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2013-002897-30
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Secondary ID [2]
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GS-US-334-0154
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HCV Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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0
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0
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Other infectious diseases
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Oral and Gastrointestinal
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0
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SOF
Treatment: Drugs - RBV
Treatment: Drugs - LDV/SOF
Experimental: SOF 200 mg + RBV 200 mg (Cohort 1) - Participants with genotype 1 or 3 HCV infection will receive SOF 200 mg (2 × 100 mg tablets) plus RBV once daily for 24 weeks.
Experimental: SOF 400 mg + RBV 200 mg (Cohort 2) - Participants with genotype 1 or 3 HCV infection will receive SOF 400 mg (4 × 100 mg tablets or 1 × 400 mg tablet) plus RBV once daily for 24 weeks.
Experimental: LDV/SOF (Cohort 3) - Participants with genotype 1 or 4 HCV infection will receive LDV/SOF once daily for 12 weeks.
Treatment: Drugs: SOF
Tablet(s) administered orally once daily
Treatment: Drugs: RBV
200 mg tablet administered orally once daily
Treatment: Drugs: LDV/SOF
90/400 mg fixed-dose combination (FDC) tablet administered orally once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
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Assessment method [1]
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SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
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Timepoint [1]
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Posttreatment Week 12
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Primary outcome [2]
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events
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Assessment method [2]
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Timepoint [2]
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Up to 24 weeks plus 30 days
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Primary outcome [3]
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Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
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Assessment method [3]
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Treatment-emergent laboratory abnormalities were defined as values that increased by at least 1 toxicity grade from baseline at any time postbaseline up to the date of last dose of study drug plus 30 days.
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Timepoint [3]
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Up to 24 weeks plus 30 days
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Primary outcome [4]
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Percentage of Participants Experiencing Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
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Assessment method [4]
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Timepoint [4]
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Up to 24 weeks plus 30 days
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Primary outcome [5]
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events Associated With Vital Sign Abnormalities
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Assessment method [5]
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Timepoint [5]
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Up to 24 weeks plus 30 days
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Primary outcome [6]
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Pharmacokinetic (PK) Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
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Assessment method [6]
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AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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Timepoint [6]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2
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Primary outcome [7]
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PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
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Assessment method [7]
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AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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Timepoint [7]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12
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Primary outcome [8]
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PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
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Assessment method [8]
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AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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Timepoint [8]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4
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Primary outcome [9]
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PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
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Assessment method [9]
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Cmax is defined as the maximum concentration of drug.
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Timepoint [9]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2
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Primary outcome [10]
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PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
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Assessment method [10]
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Cmax is defined as the maximum concentration of drug.
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Timepoint [10]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12
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Primary outcome [11]
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PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
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Assessment method [11]
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Cmax is defined as the maximum concentration of drug.
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Timepoint [11]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4
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Primary outcome [12]
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PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
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Assessment method [12]
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Ctau is defined as the observed drug concentration at the end of the dosing interval.
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Timepoint [12]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2
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Primary outcome [13]
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PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
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Assessment method [13]
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Ctau is defined as the observed drug concentration at the end of the dosing interval.
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Timepoint [13]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12
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Primary outcome [14]
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PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
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Assessment method [14]
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Ctau is defined as the observed drug concentration at the end of the dosing interval.
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Timepoint [14]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4
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Secondary outcome [1]
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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
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Assessment method [1]
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SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
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Timepoint [1]
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Posttreatment Week 4
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Secondary outcome [2]
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Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
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Assessment method [2]
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SVR4 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
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Timepoint [2]
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Posttreatment Week 24
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Secondary outcome [3]
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Percentage of Participants With Overall Virologic Failure
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Assessment method [3]
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Virologic failure was defined as:
* On-treatment virologic failure:
* Breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or
* Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
* Non-response (HCV RNA persistently = LLOQ through 8 weeks of treatment)
* Virologic relapse:
* Confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
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Timepoint [3]
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Up to Posttreatment Week 24
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Secondary outcome [4]
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PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
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Assessment method [4]
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AUClast is defined as the concentration of drug from time zero to the last observable concentration.
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Timepoint [4]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2
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Secondary outcome [5]
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PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
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Assessment method [5]
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AUClast is defined as the concentration of drug from time zero to the last observable concentration.
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Timepoint [5]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12
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Secondary outcome [6]
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PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
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Assessment method [6]
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AUClast is defined as the concentration of drug from time zero to the last observable concentration.
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Timepoint [6]
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0
Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4
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Secondary outcome [7]
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PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
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Assessment method [7]
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Clast is defined as the last observable concentration of drug.
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Timepoint [7]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2
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Secondary outcome [8]
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PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
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Assessment method [8]
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0
Clast is defined as the last observable concentration of drug.
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Timepoint [8]
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0
Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12
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Secondary outcome [9]
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0
PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
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Assessment method [9]
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0
Clast is defined as the last observable concentration of drug.
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Timepoint [9]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4
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Secondary outcome [10]
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PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
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Assessment method [10]
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Tmax is defined as the time (observed time point) of Cmax.
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Timepoint [10]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2
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Secondary outcome [11]
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PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
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Assessment method [11]
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Tmax is defined as the time (observed time point) of Cmax.
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Timepoint [11]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12
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Secondary outcome [12]
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PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
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Assessment method [12]
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Tmax is defined as the time (observed time point) of Cmax.
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Timepoint [12]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4
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Secondary outcome [13]
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PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
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Assessment method [13]
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Tlast is defined as the time (observed time point) of Clast.
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Timepoint [13]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2
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Secondary outcome [14]
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PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
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Assessment method [14]
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Tlast is defined as the time (observed time point) of Clast.
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Timepoint [14]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12
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Secondary outcome [15]
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PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
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Assessment method [15]
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Tlast is defined as the time (observed time point) of Clast.
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Timepoint [15]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4
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Secondary outcome [16]
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PK Parameter: ?z of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
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Assessment method [16]
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?z is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
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Timepoint [16]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2
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Secondary outcome [17]
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PK Parameter: ?z of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
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Assessment method [17]
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?z is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
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Timepoint [17]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12
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Secondary outcome [18]
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PK Parameter: ?z of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
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Assessment method [18]
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?z is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
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Timepoint [18]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4
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Secondary outcome [19]
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PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
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Assessment method [19]
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t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
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Timepoint [19]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2
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Secondary outcome [20]
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PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
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Assessment method [20]
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t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
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Timepoint [20]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12
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Secondary outcome [21]
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PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
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Assessment method [21]
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t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
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Timepoint [21]
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Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4
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Eligibility
Key inclusion criteria
Key
* Cohorts 1 and 2: chronic genotype 1 or 3 HCV infection
* Cohort 3: chronic genotype 1 or 4 HCV infection
* HCV RNA = 10^4 IU/mL at screening
* Screening labs within defined thresholds
* Cirrhosis determination at screening
Key
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Females who are pregnant or nursing or males who have a pregnant partner
* Prior null response to pegylated interferon (Peg-IFN)+RBV therapy (Cohorts 1 and 2) or for individuals with cirrhosis, prior treatment failure with IFN-based therapy not resulting from treatment intolerance (Cohort 3)
* Current of prior history of hepatic decompensation
* Infection with hepatitis B virus (HBV) or HIV
* History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with individual's treatment and/or adherence to the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/10/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/10/2017
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Sample size
Target
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Accrual to date
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Final
38
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Illinois
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Michigan
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Country [5]
0
0
United States of America
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State/province [5]
0
0
New York
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Texas
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Washington
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Country [8]
0
0
New Zealand
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State/province [8]
0
0
Auckland
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Country [9]
0
0
New Zealand
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State/province [9]
0
0
Christchurch
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Country [10]
0
0
Puerto Rico
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State/province [10]
0
0
San Juan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objectives of this study are to evaluate the safety and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) for 24 weeks and ledipasvir/sofosbuvir (LDV/SOF) for 12 weeks, and to evaluate the steady state pharmacokinetics (PK) of SOF and its metabolites and LDV in participants with genotype (GT) 1, 3, or 4 hepatitis C virus (HCV) infection who have chronic renal insufficiency (impaired kidney function).
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Trial website
https://clinicaltrials.gov/study/NCT01958281
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Trial related presentations / publications
Gane EJ, Robson RA, Bonacini M, Maliakkal B, Kirby B, Liu L, et al. Safety, Antiviral Efficacy, and Pharmacokinetics of Sofosbuvir in Patients With Severe Renal Impairment [Poster 966]. The 65th Annual meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); 2014 November 07-11; Boston, MA. Martin P, Gane E, Ortiz-Lasanta G, Liu L, Sajwani K, Kirby B, et al. Safety and Efficacy of Treatment With Daily Sofosbuvir 400 mg + Ribavirin 200 mg for 24 Weeks in Genotype 1 or 3 HCV-Infected Patients With Severe Renal Impairment [Poster 1128]. American Association for the Study of Liver Diseases (AASLD); 2015 November 13-17; San Francisco, CA. Lawitz E, Landis CS, Maliakkal BJ, Bonacini M, Ortiz-Lasanta G, Zhang J, et al. Safety and Efficacy of Treatment with Once- Daily Ledipasvir/Sofosbuvir (90/400 mg) for 12 Weeks in Genotype 1 HCV-Infected Patients with Severe Renal Impairment [Abstract 1587]. The Liver Meeting® 2017 - The 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2017 20-24 October; Washington, D. C. Lawitz E, Landis CS, Flamm SL, Bonacini M, Ortiz-Lasanta G, Huang J, Zhang J, Kirby BJ, De-Oertel S, Hyland RH, Osinusi AO, Brainard DM, Robson R, Maliakkal BJ, Gordon SC, Gane EJ. Sofosbuvir plus ribavirin and sofosbuvir plus ledipasvir in patients with genotype 1 or 3 hepatitis C virus and severe renal impairment: a multicentre, phase 2b, non-randomised, open-label study. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):918-926. doi: 10.1016/S2468-1253(19)30417-0. Epub 2020 Jun 10.
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Public notes
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Contacts
Principal investigator
Name
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0
Gilead Study Director
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Address
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0
Gilead Sciences
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol: Original
https://cdn.clinicaltrials.gov/large-docs/81/NCT01958281/Prot_000.pdf
Study protocol
Study Protocol: Amendment 1
https://cdn.clinicaltrials.gov/large-docs/81/NCT01958281/Prot_001.pdf
Study protocol
Study Protocol: Amendment 2
https://cdn.clinicaltrials.gov/large-docs/81/NCT01958281/Prot_002.pdf
Study protocol
Study Protocol: Amendment 3
https://cdn.clinicaltrials.gov/large-docs/81/NCT01958281/Prot_003.pdf
Study protocol
Study Protocol: Amendment 4
https://cdn.clinicaltrials.gov/large-docs/81/NCT01958281/Prot_004.pdf
Statistical analysis plan
Statistical Analysis Plan: Statistical Analysis Pl...
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https://cdn.clinicaltrials.gov/large-docs/81/NCT01958281/SAP_005.pdf
Statistical analysis plan
Statistical Analysis Plan: Statistical Analysis Pl...
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More Details
]
https://cdn.clinicaltrials.gov/large-docs/81/NCT01958281/SAP_006.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01958281
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