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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00963885




Registration number
NCT00963885
Ethics application status
Date submitted
18/08/2009
Date registered
24/08/2009
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection
Scientific title
A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio
Secondary ID [1] 0 0
2009-009608-38
Secondary ID [2] 0 0
NV21075
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
Treatment: Drugs - Pegasys
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - RO5190591 (Danoprevir)
Treatment: Drugs - RO5190591 (Danoprevir)
Treatment: Drugs - RO5190591 (Danoprevir)
Treatment: Drugs - RO5190591 (Danoprevir)

Placebo comparator: Part 1: Placebo - Placebo in combination with standard doses of Pegasys and Copegus.

Experimental: Part 1: RO5190591 300mg po - RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus.

Experimental: Part 1: RO5190591 600mg po - RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus.

Experimental: Part 1: RO5190591 900mg po - RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.

Placebo comparator: Part 2: Placebo - If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive placebo in combination with standard doses of Pegasys and Copegus.

Experimental: Part 2: RO5190591 300mg po - If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.


Treatment: Drugs: Copegus
1000 or 1200mg po daily for 24 or 48 weeks

Treatment: Drugs: Pegasys
180micrograms sc weekly for 24 or 48 weeks

Treatment: Drugs: Placebo
po for 12 weeks

Treatment: Drugs: Placebo
po for 24 weeks

Treatment: Drugs: RO5190591 (Danoprevir)
300mg po q8h for 12 weeks

Treatment: Drugs: RO5190591 (Danoprevir)
600mg po q12h for 12 weeks

Treatment: Drugs: RO5190591 (Danoprevir)
900mg po q12h for 12 weeks

Treatment: Drugs: RO5190591 (Danoprevir)
300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sustained virological response
Timepoint [1] 0 0
24 weeks after end of treatment
Secondary outcome [1] 0 0
Virological response over time
Timepoint [1] 0 0
At 2- to 6-weekly intervals throughout study; at end of treatment; 12 weeks post-treatment
Secondary outcome [2] 0 0
Adverse events; laboratory parameters
Timepoint [2] 0 0
Throughout study, laboratory parameters every 2 to 6 weeks

Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* chronic hepatitis C, genotype 1;
* treatment-naive.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* liver cirrhosis and other forms of liver disease;
* HIV infection;
* hepatocellular cancer;
* cardiac disease.

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
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
229
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
- Kingswood
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Heidelberg
Recruitment postcode(s) [1] 0 0
- Kingswood
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
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
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
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
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Austria
State/province [16] 0 0
Wien
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Manitoba
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
France
State/province [21] 0 0
Clichy
Country [22] 0 0
France
State/province [22] 0 0
Marseille
Country [23] 0 0
France
State/province [23] 0 0
Montpellier
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
Germany
State/province [25] 0 0
Frankfurt Am Main
Country [26] 0 0
Germany
State/province [26] 0 0
Hamburg
Country [27] 0 0
Italy
State/province [27] 0 0
Campania

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

Ethics approval
Ethics application status

Summary
Brief summary
This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/study/NCT00963885
Trial related presentations / publications
Marcellin P, Cooper C, Balart L, Larrey D, Box T, Yoshida E, Lawitz E, Buggisch P, Ferenci P, Weltman M, Labriola-Tompkins E, Le Pogam S, Najera I, Thomas D, Hooper G, Shulman NS, Zhang Y, Navarro MT, Lim CY, Brunda M, Terrault NA, Yetzer ES. Randomized controlled trial of danoprevir plus peginterferon alfa-2a and ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection. Gastroenterology. 2013 Oct;145(4):790-800.e3. doi: 10.1053/j.gastro.2013.06.051. Epub 2013 Jun 26.
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/study/NCT00963885