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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01773070
Registration number
NCT01773070
Ethics application status
Date submitted
19/11/2012
Date registered
23/01/2013
Date last updated
6/12/2017
Titles & IDs
Public title
A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study
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Scientific title
A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
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Secondary ID [1]
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2012-003073-26
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Secondary ID [2]
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M13-102
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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:
Snoring
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Hepatitis C
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Condition category
Condition code
Infection
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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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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Respiratory
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0
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Sleep apnoea
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Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABT-450/ritonavir
Treatment: Drugs - ABT-333
Treatment: Drugs - ABT-267
Treatment: Devices - Tongue Advancement Retainer Device
Other: All Participants - Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Experimental: Device Treatment - Tongue Advancement Retainer Device
Treatment: Drugs: ABT-450/ritonavir
ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.
Treatment: Drugs: ABT-333
Drug is not administered -- this study is follow-up for participants previously receiving the drug.
Treatment: Drugs: ABT-267
Drug is not administered -- this study is follow-up for participants previously receiving the drug.
Treatment: Devices: Tongue Advancement Retainer Device
Tongue Advancement Retainer Device
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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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 Who Experienced Relapse12overall With and Without New HCV Infection
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Assessment method [1]
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Relapse is defined as a confirmed HCV ribonucleic acid (RNA) = the lower limit of quantitation (LLOQ) at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse12overall is defined as a confirmed HCV RNA = LLOQ at any time after the sustained virologic response at Week 12 post-dosing (SVR12) assessment time point for a participant who achieved SVR12 and had post-SVR12 HCV RNA data available. SVR12 is defined as HCV RNA \< LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. New HCV infection is defined as re-infection with a different HCV isolate.
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Timepoint [1]
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Up to 3 years post-treatment
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Primary outcome [2]
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Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B
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Assessment method [2]
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The persistence of specific hepatitis C amino acid variants (treatment-emergent substitutions) associated with drug resistance in NS3, NS5A, or NS5B was evaluated in participants who had not achieved SVR12. Post-baseline time points were calculated relative to the last dose of study drug in the previous study.
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Timepoint [2]
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from the last dose of study drug in the previous study up to 3 years post-treatment
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Primary outcome [3]
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Primary Safety Endpoint - The safety of the device will be measured through recorded observations of adverse events.
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Assessment method [3]
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Safety endpoint will be measured throughout the duration of the study.
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Timepoint [3]
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Approximately 6 weeks
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Primary outcome [4]
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The safety and tolerability of single and multiple doses of HMPL-504 administered to patients.
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Assessment method [4]
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The primary endpoint is evaluation of safety and tolerability during all the study of therapy following the initiation of multiple dosing of HMPL-504. The safety and tolerability variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology(Maximum Tolerated Dose) , and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate,Incidence and nature of DLTs(Dose-Limiting Toxicity),To determine the MTD (Maximum Tolerated Dose).
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Timepoint [4]
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up to 20 months
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Secondary outcome [1]
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Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection
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Assessment method [1]
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Relapse is defined as a confirmed HCV RNA = LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse12 is defined as a confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment.
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Timepoint [1]
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From the end of treatment through 12 weeks post-treatment
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Secondary outcome [2]
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Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection
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Assessment method [2]
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Relapse is defined as a confirmed HCV RNA = LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse24 is defined as a confirmed HCV RNA = LLOQ within the sustained virologic response at Week 24 post-dosing (SVR24) window for a participant who achieved SVR12 and had HCV RNA data available in the SVR24 window.
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Timepoint [2]
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From the end of treatment through 24 weeks post-treatment
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Secondary outcome [3]
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Percentage of Participants Who Experienced Relapse?Overall Without and With New HCV Infection
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Assessment method [3]
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Relapse is defined as a confirmed HCV RNA = LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse?overall was defined as a confirmed HCV RNA = LLOQ between end of treatment and up to and including the last HCV RNA measurement collected in the post-treatment Period for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment.
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Timepoint [3]
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Up to 3 years post-treatment
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Secondary outcome [4]
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Primary Efficacy Endpoint - Change in the overall Apnea Hypopnea Index (AHI) from the PSG at baseline and end of treatment phase.
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Assessment method [4]
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Efficacy Endpoint will be measured at baseline and at end of treatment.
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Timepoint [4]
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Approximately 6 weeks
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Secondary outcome [5]
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Pharmacokinetic Assessments for area under curve (AUC), Cmax and Tmax .
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Assessment method [5]
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In the study of single-dose, full Pharmacokinetics(PK) profiles of HMPL-504 will be obtained following administration of a single oral dose of HMPL-504 on Day 1 to Day 3. At multiple-dose, Pharmacokinetics(PK) sampling will include a pre-dose and at the 0.5,2,4,6,8 hour time points on days 1,15,21of dosing in the first 21-Day cycle of therapy, and pre-dose on days 2,8,16,and 22 of the first 21-Day cycle of therapy
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Timepoint [5]
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Day 1-3 Single Dose and Day 1-21 Steady State
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Eligibility
Key inclusion criteria
* Subject has received at least one dose of ABT-450, ABT-333 or ABT-267 in a prior AbbVie HCV Phase 2 or 3 study which is being submitted as a US IND.
* The interval between the last dose of the AbbVie DAA therapy from the previous clinical study and enrollment in Study M13-102 must be no longer than 2 years.
* The subject must voluntarily sign and date the informed consent form.
* Subject completed the post-treatment period of an eligible prior study.
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Minimum age
18
Years
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Maximum age
80
Years
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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
* The investigator considers the subject unsuitable for the study for any reasons.
* Receipt of any investigational product from Day 1 and while enrolled in this study.
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Study design
Purpose of the study
Other
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Allocation to intervention
NA
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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
Single group
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Other design features
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Phase
Phase 3
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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
1/06/2013
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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
1/10/2016
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Sample size
Target
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Accrual to date
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Final
478
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Royal North Shore Hospital - St. Leonards
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Recruitment hospital [2]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [3]
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Southern Health and Monash Institute of Medical Research - Clayton
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Recruitment hospital [4]
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Austin Health - Melbourne
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Recruitment postcode(s) [1]
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2065 - St. Leonards
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3084 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie (prior sponsor, Abbott)
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Sir Charles Gairdner Hospital
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Austin Hospital, Melbourne Australia
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Monash University
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
A follow-up study to assess resistance and durability of response to 3 experimental drugs ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3 clinical studies with these agents for the treatment of chronic hepatitis C virus (HCV). Studies include: M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998 (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389 (NCT01674725)' M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and M14-103 (NCT01911845).
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Trial website
https://clinicaltrials.gov/study/NCT01773070
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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AbbVie Inc
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01773070
Download to PDF