Clinical Trial Protocol Registry

Trial information

A Study of Mericitabine in Combination With Telaprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

Status:
Active, not recruiting
Protocol number:
NV27779
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific Title:
A PHASE II, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PARALLEL GROUP STUDY TO EVALUATE THE SUSTAINED VIROLOGIC RESPONSE OF THE HCV POLYMERASE INHIBITOR PRODRUG RO5024048 IN COMBINATION WITH TELAPREVIR AND PEGASYS®/COPEGUS® IN PATIENTS WITH CHRONIC HEPATITIS C GENOTYPE 1 VIRUS INFECTION WHO WERE PRIOR
Brief summary:
This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with telaprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks. Target sample size is 80.
Study phase:
II
Study type:
Interventional; Treatment; Randomized; Double Blind; Parallel; Safety/efficacy study
Conditions:
  • Hepatitis C, Chronic
Primary outcome:
  1. Sustained virological response 12 weeks after treatment (SVR-12) Time frame: up to 60 weeks
Key secondary outcomes:
  1. Sustained virological response 4 weeks after treatment (SVR-4) Time frame: up to 52 weeks
  2. Virologic response over time Time frame: 60 weeks
  3. Proportion of patients who develop treatment resistance Time frame: 60 weeks
  4. Safety (incidence of adverse events) Time frame: 60 weeks
  5. Pharmacokinetics: trough concentration of RO4995855 Time frame: Day 1 and Week 8
  6. Pharmacokinetics: trough concentration of RO5012433 Time frame: Day 1 and Week 8
  7. Pharmacokinetics: trough concentration of telaprevir Time frame: Day 1 and Week 8
Inclusion criteria:
  • Adult patients, >/=18 years of age
  • Chronic hepatitis C infection for at least 6 months duration
  • Hepatitis C genotype 1a or 1b
  • Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
  • Patients showed a previous null response to therapy as defined by < 2 log10 IU/ml decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV
Exclusion criteria:
  • Hepatitis C infection with a genotype other than genotype 1a or 1b
  • Body mass index <18 or >/=36
  • Hepatitis A, hepatitis B, or HIV infection
  • Herbal remedies </=1 month prior to the first dose of study drug
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
December, 2011
Trial registration date:
10.10.2011
Date last updated:
10.06.2013
This trial was conducted at the following locations:
Canada
  • VANCOUVER, BC
  • VICTORIA, BC
  • TORONTO, ON
CANADA
  • Winnipeg, Manit
  • Woodbridge, Ontar
  • Montreal, Quebe
France
  • LILLE
  • MARSEILLE
  • TOULOUSE
Germany
  • FRANKFURT AM MAIN
  • FREIBURG
  • KIEL
Italy
  • BOLOGNA
  • PISA
ITALY
  • MILANO
Spain
  • BARCELONA
  • LA LAGUNA
SPAIN
  • BARCELONA, BARCE
  • MADRID, MADRI
U.S.A.
  • FRAMINGHAM, MA
  • STATESVILLE, NC
  • CINCINNATI, OH
  • RICHMOND, VA
United Kingdom
  • LONDON
UNITED KINGDOM
  • Dorset
  • London
UNITED STATES
  • Birmingham, AL
  • Long Beach, CA
  • Sacramento, CA
  • San Diego, CA
  • New Haven, CT
  • Naples, FL
  • Lutherville, MD
  • St. Louis, MO
  • New York, NY
  • Dallas, TX
  • SEATTLE, WA

Link to trial result

For more information on a specific Roche trials in your country location, please contact your local Roche affiliate nearest you.

  • Go on the URL link- http://www.roche.com and click on the Roche Worldwide tab on the top of the page to locate the country nearest you for contact information.

Treatment decisions and/or suitability for a specific trial are decisions only your healthcare provider can make. If you are patient interested in any of the global studies, please have your healthcare provider contact us and they will be provided with the relevant clinical trial information.

For US or global trials with US sites only, please contact the Trial Information Support Line (TISL)