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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01185860




Registration number
NCT01185860
Ethics application status
Date submitted
19/08/2010
Date registered
20/08/2010
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1
Scientific title
A Multiple-Dose Study To Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted RO5190591 in Combination With Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1
Secondary ID [1] 0 0
2009-012426-36
Secondary ID [2] 0 0
NP22660
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - danoprevir
Treatment: Drugs - peginterferon alfa-2a [Pegasys]
Treatment: Drugs - placebo
Treatment: Drugs - ribavirin
Treatment: Drugs - ritonavir

Active comparator: A -

Experimental: B -

Placebo comparator: C -


Treatment: Drugs: danoprevir
oral doses

Treatment: Drugs: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly

Treatment: Drugs: placebo
oral doses

Treatment: Drugs: ribavirin
1000-1200mg/day po

Treatment: Drugs: ritonavir
oral doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability: Adverse events, ECG, laboratory parameters
Timepoint [1] 0 0
approximately 3 years
Primary outcome [2] 0 0
Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2
Timepoint [2] 0 0
Days 3-9
Primary outcome [3] 0 0
Antiviral activity: HCV RNA (COBAS Taqman HCV Test)
Timepoint [3] 0 0
from baseline to Day 28
Secondary outcome [1] 0 0
Viral resistance development
Timepoint [1] 0 0
from baseline to Day 17
Secondary outcome [2] 0 0
Effects on cytochrome P450(CYP)2C9 and 3A isozymes
Timepoint [2] 0 0
from baseline to Day 17
Secondary outcome [3] 0 0
Virological response in prior null-responders
Timepoint [3] 0 0
from baseline to week 72
Secondary outcome [4] 0 0
Comparison of pharmacokinetics and antiviral activity between treatment-naïve patients and prior null-responders to standard of care treatment
Timepoint [4] 0 0
approximately 3 years

Eligibility
Key inclusion criteria
* Adults, 18-65 years of age
* Chronic hepatitis C genotype 1
* HCV treatment naïve, or without sustained virologic response on prior PEG-INF/RBV treatment
* Body mass index (BMI) 18 - 35 kg/m2, inclusive; minimum weight 45 kg
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Liver cirrhosis
* Decompensated liver disease or impaired liver function
* Medical condition associated with chronic liver disease other than chronic hepatitis C
* Positive for hepatitis B or HIV infection at screening
* History of alcohol consumption exceeding 2 standard drinks per day when averaged over the course of a given week

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Montpellier
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Grafton
Country [4] 0 0
Poland
State/province [4] 0 0
Warszawa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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 not provided in https://clinicaltrials.gov/study/NCT01185860