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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01278134




Registration number
NCT01278134
Ethics application status
Date submitted
14/01/2011
Date registered
17/01/2011
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)
Scientific title
INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment With a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients
Secondary ID [1] 0 0
2010-022067-35
Secondary ID [2] 0 0
PP25213
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 - Copegus placebo
Treatment: Drugs - RO5024048
Treatment: Drugs - danoprevir
Treatment: Drugs - peginterferon alfa-2a [Pegasys]
Treatment: Drugs - ribavirin [Copegus]
Treatment: Drugs - ritonavir

Experimental: Arm B Extension - All patients in treatment arm B were offered to receive Pegasys/Cogepus therapy for an additional 24 weeks.

Experimental: RO5024048 & ritonavir-boosted danoprevir without Ribavirin (B) -

Experimental: RO5024048 and ritonavir-boosted danoprevir with Ribavirin (A) -


Treatment: Drugs: Copegus placebo
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks

Treatment: Drugs: RO5024048
1000 mg bid orally, up to 24 weeks

Treatment: Drugs: danoprevir
100 mg bid orally, up to 24 weeks

Treatment: Drugs: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 24 weeks

Treatment: Drugs: ribavirin [Copegus]
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks

Treatment: Drugs: ritonavir
100 mg bid orally, up to 24 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sustained virological response, defined as undetectable HVC RNA measured by Roche COBAS TaqMan HCV test
Timepoint [1] 0 0
24 weeks after end of treatment
Primary outcome [2] 0 0
Safety: Incidence of adverse events
Timepoint [2] 0 0
1.5 years
Secondary outcome [1] 0 0
Virological response (HCV RNA measured by Roche COBAS Taqman HCV test)
Timepoint [1] 0 0
up to 48 weeks
Secondary outcome [2] 0 0
Impact of Copegus (ribavirin) on efficacy of the direct-acting antiviral combination regimen: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)
Timepoint [2] 0 0
1.5 years
Secondary outcome [3] 0 0
Comparison of 12 and 24 weeks of treatment duration: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)
Timepoint [3] 0 0
1.5 years
Secondary outcome [4] 0 0
Pharmacokinetics: Plasma concentrations of danoprevir, ritonavir, RO4995855 (parent drug of RO5024048) and ribavirin
Timepoint [4] 0 0
up to 24 weeks
Secondary outcome [5] 0 0
Viral resistance: HCV RNA sequencing and phenotypic analyses
Timepoint [5] 0 0
up to 48 weeks
Secondary outcome [6] 0 0
Effect of interleukin 28B genotype on efficacy: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)
Timepoint [6] 0 0
1.5 years
Secondary outcome [7] 0 0
Quality of life: SF-36 questionnaire, Fatigue Severity Scale
Timepoint [7] 0 0
up to 36 weeks

Eligibility
Key inclusion criteria
* Adult patient, >/= 18 years of age
* Chronic Hepatitis C of >/= 6 months duration at screening
* HCV genotype 1 and quantifiable HCV RNA at screening (Roche COBAS TaqMan HCV test)
* Naïve for treatment with interferon (pegylated or non-pegylated)
* Body Mass Index (BMI) 18-35 inclusive, minimum weight 45 kg
* Females of child-bearing potential and males with female partners of childbearing potential must use 2 forms of effective non-hormonal contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or lactating women and males with female partners who are pregnant or lactating
* Decompensated liver disease or impaired liver function
* Cirrhosis or incomplete/transition to cirrhosis
* Non-hepatitis C chronic liver disease
* Hepatitis B or HIV infection
* History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
* History of pre-existing renal disease (except for nephrolithiasis) or severe cardiac disease
* History of drug or alcohol abuse within the last year or alcohol consumption of > 2 units per day; cannabinoid use is excepted

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


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
170
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Rhode Island
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
France
State/province [17] 0 0
Clichy
Country [18] 0 0
France
State/province [18] 0 0
Creteil
Country [19] 0 0
France
State/province [19] 0 0
Lille
Country [20] 0 0
France
State/province [20] 0 0
Marseille
Country [21] 0 0
France
State/province [21] 0 0
Montpellier
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Frankfurt Am Main
Country [25] 0 0
Germany
State/province [25] 0 0
Hamburg
Country [26] 0 0
Germany
State/province [26] 0 0
Hannover
Country [27] 0 0
Germany
State/province [27] 0 0
Kiel
Country [28] 0 0
Germany
State/province [28] 0 0
Leipzig
Country [29] 0 0
New Zealand
State/province [29] 0 0
Grafton

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/NCT01278134