A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C
Completed · Phase 2 · Has a placebo group
Conditions studied: Hepatitis C
In brief
This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.
Key facts
- Study ID
- NCT01482390
- Run by
- Hoffmann-La Roche
- People needed
- 80
- Starts
- 2011-11-30
- Expected to finish
- 2014-01-31
- Last updated by the study team
- 2017-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Chronic hepatitis C infection for at least 6 months duration
- Hepatitis C genotype 1a or 1b
- Participants must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
- Participants showed a previous null response to therapy as defined by < 2 logarithm to the base 10 (log10) international units per milliliter (IU/mL) decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV
You may not qualify if…
- Hepatitis C infection with a genotype other than genotype 1a or 1b
- Body mass index < 18 or >= 36 kilograms per square meters (kg/m\^2)
- Hepatitis A, hepatitis B, or human immunodeficiency virus (HIV) infection
- Herbal remedies <=1 month prior to the first dose of study drug
Where it is running
- Birmingham Gastro Associates, P.C. — Birmingham, Alabama, United States
- VA Long Beach Healthcare System — Long Beach, California, United States
- Kaiser Permanente Sacramento Medical Center — Sacramento, California, United States
- UCSD Antiviral Research Center — San Diego, California, United States
- Yale University — New Haven, Connecticut, United States
- Gastroenterology Group of Naples — Naples, Florida, United States
- John Hopkins Hospital — Lutherville, Maryland, United States
- Metrowest Medical Center — Framingham, Massachusetts, United States
- Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit — St Louis, Missouri, United States
- Weill Cornell Medical College — New York, New York, United States
- Carolina'S Center For Liver Disease — Statesville, North Carolina, United States
- Uni of Cincinnati College of Medicine; Div. of Digestive Diseases — Cincinnati, Ohio, United States
- Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons — Dallas, Texas, United States
- McGuire; Veteran Affairs Med Ctr — Richmond, Virginia, United States
- Harborview Medical Center — Seattle, Washington, United States
- Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology — Vancouver, British Columbia, Canada
- GI Research Institute; Gastroenterology & Hepatology — Vancouver, British Columbia, Canada
- Percuro Clinical Research Ltd. — Victoria, British Columbia, Canada
- Winnipeg Regional Health Authority; Section of Hepatology — Winnipeg, Manitoba, Canada
- University Health Network - Toronto Western Hospital; Hepatology — Toronto, Ontario, Canada
- Toronto Digest. Disease Asso. — Woodbridge, Ontario, Canada
- McGill University, Montreal Chest Institute; Viral and other Infectious — Montreal, Quebec, Canada
- Hopital Claude Huriez;Gastro Enterologie — Lille, France
- Fondation Hopital Saint Joseph; Gastro-Enterologie — Marseille, France
- Hopital Purpan;Gastro Enterologie Hepatologie — Toulouse, France
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.