A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C
- Conditions
- Hepatitis C
- Interventions
- Registration Number
- NCT01482390
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks) Peginterferon Alfa-2a Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV and then 12 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks) Placebo Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with placebo matching to MCB and PEG-IFN/RBV, and then 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks) Peginterferon Alfa-2a Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV (total treatment duration of 24 weeks). TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks) Telaprevir Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV and then 12 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks) Placebo Twelve weeks of therapy with placebo matching to MCB, TVR, PEG-IFN/RBV, will be followed by 12 weeks of therapy with placebo matching to MCB along with PEG-IFN/RBV , following 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks) Ribavirin Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV (total treatment duration of 24 weeks). TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks) Mericitabine Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV (total treatment duration of 24 weeks). TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks) Telaprevir Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV (total treatment duration of 24 weeks). TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks) Ribavirin Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV and then 12 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks) Telaprevir Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with placebo matching to MCB and PEG-IFN/RBV, and then 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks) Peginterferon Alfa-2a Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with placebo matching to MCB and PEG-IFN/RBV, and then 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks) Ribavirin Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with placebo matching to MCB and PEG-IFN/RBV, and then 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks) Ribavirin Twelve weeks of therapy with placebo matching to MCB, TVR, PEG-IFN/RBV, will be followed by 12 weeks of therapy with placebo matching to MCB along with PEG-IFN/RBV , following 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks) Peginterferon Alfa-2a Twelve weeks of therapy with placebo matching to MCB, TVR, PEG-IFN/RBV, will be followed by 12 weeks of therapy with placebo matching to MCB along with PEG-IFN/RBV , following 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks) Telaprevir Twelve weeks of therapy with placebo matching to MCB, TVR, PEG-IFN/RBV, will be followed by 12 weeks of therapy with placebo matching to MCB along with PEG-IFN/RBV , following 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks) Mericitabine Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV and then 12 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks) Mericitabine Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with placebo matching to MCB and PEG-IFN/RBV, and then 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).
- Primary Outcome Measures
Name Time Method Percent of Participants With Sustained Virological Response 12 Weeks After End of Treatment (SVR12), as Determined by Polymerase Chain Reaction (PCR) Using Roche COBAS TaqMan Hepatitis C Virus (HCV) Test 12 weeks after end of treatment (up to Week 60)
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology Baseline up to Week 60 Change From Baseline in HCV Ribonucleic Acid (RNA) Levels Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72 Trough Concentration of RO4995855 (Parent Drug of Mericitabine) Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8 Percentage of Participants With Adverse Event Baseline up to Week 72 Trough Concentration of Telaprevir Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8 Percentage of Participants With Sustained Virological Response 4 Weeks After End of Treatment (SVR-4), as Determined by PCR Using Roche COBAS TaqMan HCV Test 4 weeks after end of treatment (up to Week 52) Percentage of Participants With Virological Response Over Time From Week 2 to Week 48, as Determined by PCR Using Roche COBAS TaqMan HCV Test Weeks 2, 4, 12, 24, and 48 Percentage of Participants With Sustained Virological Response 24 Weeks After End of Treatment (SVR-24), as Determined by PCR Using Roche COBAS TaqMan HCV Test 24 weeks after end of treatment (up to Week 72) Trough Concentration of Metabolite of RO4995855 (RO5012433) Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8
Trial Locations
- Locations (39)
Carolina'S Center For Liver Disease
🇺🇸Statesville, North Carolina, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Birmingham Gastro Associates, P.C.
🇺🇸Birmingham, Alabama, United States
Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons
🇺🇸Dallas, Texas, United States
Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology
🇨🇦Vancouver, British Columbia, Canada
Winnipeg Regional Health Authority; Section of Hepatology
🇨🇦Winnipeg, Manitoba, Canada
GI Research Institute; Gastroenterology & Hepatology
🇨🇦Vancouver, British Columbia, Canada
Percuro Clinical Research Ltd.
🇨🇦Victoria, British Columbia, Canada
Weill Cornell Medical College
🇺🇸New York, New York, United States
Yale University
🇺🇸New Haven, Connecticut, United States
McGill University, Montreal Chest Institute; Viral and other Infectious
🇨🇦Montreal, Quebec, Canada
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
UCSD Antiviral Research Center
🇺🇸San Diego, California, United States
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
John Hopkins Hospital
🇺🇸Lutherville, Maryland, United States
Kaiser Permanente Sacramento Medical Center
🇺🇸Sacramento, California, United States
Metrowest Medical Center
🇺🇸Framingham, Massachusetts, United States
Uni of Cincinnati College of Medicine; Div. of Digestive Diseases
🇺🇸Cincinnati, Ohio, United States
Toronto Digest. Disease Asso.
🇨🇦Woodbridge, Ontario, Canada
McGuire; Veteran Affairs Med Ctr
🇺🇸Richmond, Virginia, United States
Hopital Claude Huriez;Gastro Enterologie
🇫🇷Lille, France
Fondation Hopital Saint Joseph; Gastro-Enterologie
🇫🇷Marseille, France
University Health Network - Toronto Western Hospital; Hepatology
🇨🇦Toronto, Ontario, Canada
Hospital Universitario de Canarias; Servicio de Digestivo
🇪🇸La Laguna, Tenerife, Spain
Hopital Purpan;Gastro Enterologie Hepatologie
🇫🇷Toulouse, France
UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
🇮🇹Bologna, Emilia-Romagna, Italy
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
🇩🇪Frankfurt Am Main, Germany
Uniklinik Freiburg; Abteilung Innere Medizin II
🇩🇪Freiburg, Germany
Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
🇮🇹Pisa, Toscana, Italy
Universitäts Klinikum; Schleswig-Holstein Kiel
🇩🇪Kiel, Germany
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive
🇮🇹Milano, Lombardia, Italy
Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas
🇪🇸Barcelona, Spain
Hospital Clinic I Provincial; Servicio de Digestivo
🇪🇸Barcelona, Spain
Royal Bournemouth Hospital, Gastroenterology
🇬🇧Dorset, United Kingdom
Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility
🇬🇧London, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
King'S College Hospital; Institute of Liver Studies
🇬🇧London, United Kingdom
Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
🇺🇸Saint Louis, Missouri, United States
Hospital Carlos III; Laboratorio de Biologia Molecular
🇪🇸Madrid, Spain