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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01483742




Registration number
NCT01483742
Ethics application status
Date submitted
30/11/2011
Date registered
1/12/2011
Date last updated
1/08/2016

Titles & IDs
Public title
A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
Scientific title
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted DANOPREVIR and RO5024048 in Different Combinations in Null Responder or Treatment Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
Secondary ID [1] 0 0
2011-004129-28
Secondary ID [2] 0 0
NP27946
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 - RO5024048
Treatment: Drugs - danoprevir
Treatment: Drugs - peginterferon alfa-2a [Pegasys]
Treatment: Drugs - ribavirin
Treatment: Drugs - ritonavir

Experimental: Combination without RO5024048 - Ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients

Experimental: Combination with RO5024048 - RO5024048 added to the combination treatment (ritonavir-boosted danoprevir in combination with Pegasys [peginterferon alfa-2a] and ribavirin) in prior null responder patients


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

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

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

Treatment: Drugs: ribavirin
1000-1200 mg/kg/day orally in two divided doses, 24 weeks

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

Outcomes
Primary outcome [1] 0 0
Safety: Incidence of adverse events
Timepoint [1] 0 0
48 weeks
Primary outcome [2] 0 0
Pharmacokinetics (PK): Area under the concentration-time curve (AUC)
Timepoint [2] 0 0
Intensive PK sample collection during initial 2 week dosing period, followed by routine sampling during treatment up to Week 24
Primary outcome [3] 0 0
Antiviral activity: Hepatitis C virus (HCV) RNA levels assessed by Roche COBAS Taqman HCV Test
Timepoint [3] 0 0
48 weeks
Secondary outcome [1] 0 0
Emergence of viral resistance: HCV RNA gene sequence variations
Timepoint [1] 0 0
From baseline to Week 48
Secondary outcome [2] 0 0
Virologic response: HCV RNA levels
Timepoint [2] 0 0
approximately 1 year

Eligibility
Key inclusion criteria
- Adult patients, 18 to 65 years of age inclusive

- Chronic hepatitis C, genotype 1 or 4

- Cohort 1: Treatment-naïve for hepatitis C

- Cohort 2: Prior null responder to treatment with approved doses of pegylated
interferon plus ribavirin

- Liver biopsy confirming cirrhosis

- Compensated cirrhosis (Child-Pugh A)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or lactating women or male partners of women who are pregnant

- History or presence of decompensated liver disease (ascites, hepatic encephalopathy,
hepatocellular carcinoma, or bleeding esophageal varices)

- Cohort 2: Patients who discontinued previous pegylated interferon plus ribavirin
treatment due to reasons other than null response

- History of clinically significant cardiovascular or cerebrovascular disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
- Fitzroy
Recruitment hospital [2] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3124 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
France
State/province [12] 0 0
Montpellier
Country [13] 0 0
New Zealand
State/province [13] 0 0
Auckland
Country [14] 0 0
New Zealand
State/province [14] 0 0
Christchurch
Country [15] 0 0
Poland
State/province [15] 0 0
Chorzów
Country [16] 0 0
Poland
State/province [16] 0 0
Myslowice
Country [17] 0 0
Poland
State/province [17] 0 0
Warszawa
Country [18] 0 0
Poland
State/province [18] 0 0
Wroclaw
Country [19] 0 0
Slovakia
State/province [19] 0 0
Bratislava

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

Ethics approval
Ethics application status

Summary
Brief summary
This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and
antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon
alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the
combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or
4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily
(bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin
1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid
additionally. Anticipated time on study treatment is 24 weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01483742
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01483742