This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01482390
First received: November 28, 2011
Last updated: April 21, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Hepatitis C Drug: Ribavirin Drug: Mericitabine Drug: Peginterferon Alfa-2a Drug: Placebo Drug: Telaprevir Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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 Null Responders to Treatment With Pegylated Interferon/Ribavirin

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 [ Time Frame: 12 weeks after end of treatment (up to Week 60) ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 4 weeks after end of treatment (up to Week 52) ]
  • 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 [ Time Frame: 24 weeks after end of treatment (up to Week 72) ]
  • Percentage of Participants With Virological Response Over Time From Week 2 to Week 48, as Determined by PCR Using Roche COBAS TaqMan HCV Test [ Time Frame: Weeks 2, 4, 12, 24, and 48 ]
  • Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology [ Time Frame: Baseline up to Week 60 ]
  • Change From Baseline in HCV Ribonucleic Acid (RNA) Levels [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72 ]
  • Percentage of Participants With Adverse Event [ Time Frame: Baseline up to Week 72 ]
  • Trough Concentration of RO4995855 (Parent Drug of Mericitabine) [ Time Frame: 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 ]
  • Trough Concentration of Metabolite of RO4995855 (RO5012433) [ Time Frame: 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 ]
  • Trough Concentration of Telaprevir [ Time Frame: 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 ]

Enrollment: 80
Actual Study Start Date: November 30, 2011
Study Completion Date: January 31, 2014
Primary Completion Date: January 31, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks)
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).
Drug: Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than [<] 75 kg) or 1200 mg (for participants weighing greater than or equal to [>=] 75 kg) orally for 24 or 48 weeks.
Other Name: Copegus
Drug: Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
Drug: Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Other Name: Pegasys
Drug: Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
Experimental: TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks)
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).
Drug: Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than [<] 75 kg) or 1200 mg (for participants weighing greater than or equal to [>=] 75 kg) orally for 24 or 48 weeks.
Other Name: Copegus
Drug: Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
Drug: Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Other Name: Pegasys
Drug: Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
Experimental: TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)
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).
Drug: Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than [<] 75 kg) or 1200 mg (for participants weighing greater than or equal to [>=] 75 kg) orally for 24 or 48 weeks.
Other Name: Copegus
Drug: Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
Drug: Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Other Name: Pegasys
Drug: Placebo
Participants will receive placebo matching to mericitabine orally twice daily.
Drug: Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
Active Comparator: TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks)
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).
Drug: Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than [<] 75 kg) or 1200 mg (for participants weighing greater than or equal to [>=] 75 kg) orally for 24 or 48 weeks.
Other Name: Copegus
Drug: Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Other Name: Pegasys
Drug: Placebo
Participants will receive placebo matching to mericitabine orally twice daily.
Drug: Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482390

  Hide Study Locations
Locations
United States, Alabama
Birmingham Gastro Associates, P.C.
Birmingham, Alabama, United States, 35209
United States, California
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States, 95825
UCSD Antiviral Research Center
San Diego, California, United States, 92103
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
United States, Florida
Gastroenterology Group of Naples
Naples, Florida, United States, 34102
United States, Maryland
John Hopkins Hospital
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Metrowest Medical Center
Framingham, Massachusetts, United States, 01702
United States, Missouri
Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
Saint Louis, Missouri, United States, 63104
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
United States, North Carolina
Carolina'S Center For Liver Disease
Statesville, North Carolina, United States, 28677
United States, Ohio
Uni of Cincinnati College of Medicine; Div. of Digestive Diseases
Cincinnati, Ohio, United States, 45267-0595
United States, Texas
Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons
Dallas, Texas, United States, 75246
United States, Virginia
McGuire; Veteran Affairs Med Ctr
Richmond, Virginia, United States, 23249
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Canada, British Columbia
Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology
Vancouver, British Columbia, Canada, V5Z 1M9
GI Research Institute; Gastroenterology & Hepatology
Vancouver, British Columbia, Canada, V6Z 2K5
Percuro Clinical Research Ltd.
Victoria, British Columbia, Canada, V8V 3P9
Canada, Manitoba
Winnipeg Regional Health Authority; Section of Hepatology
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
University Health Network - Toronto Western Hospital; Hepatology
Toronto, Ontario, Canada, M5G 1L7
Toronto Digest. Disease Asso.
Woodbridge, Ontario, Canada, L4L 4Y7
Canada, Quebec
McGill University, Montreal Chest Institute; Viral and other Infectious
Montreal, Quebec, Canada, H2X2P4
France
Hopital Claude Huriez;Gastro Enterologie
Lille, France, 59037
Fondation Hopital Saint Joseph; Gastro-Enterologie
Marseille, France, 13285
Hopital Purpan;Gastro Enterologie Hepatologie
Toulouse, France, 31059
Germany
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
Frankfurt Am Main, Germany, 60590
Uniklinik Freiburg; Abteilung Innere Medizin II
Freiburg, Germany, 79106
Universitäts Klinikum; Schleswig-Holstein Kiel
Kiel, Germany, 24105
Italy
UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
Bologna, Emilia-Romagna, Italy, 40138
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive
Milano, Lombardia, Italy, 20162
Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
Pisa, Toscana, Italy, 56124
Spain
Hospital Universitario de Canarias; Servicio de Digestivo
La Laguna, Tenerife, Spain, 38320
Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas
Barcelona, Spain, 08035
Hospital Clinic I Provincial; Servicio de Digestivo
Barcelona, Spain, 08036
Hospital Carlos III; Laboratorio de Biologia Molecular
Madrid, Spain, 28029
United Kingdom
Royal Bournemouth Hospital, Gastroenterology
Dorset, United Kingdom, BH7 7DW
King'S College Hospital; Institute of Liver Studies
London, United Kingdom, SE5 9RS
St George's Hospital
London, United Kingdom, SW17 0QT
Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01482390     History of Changes
Other Study ID Numbers: NV27779
2011-002715-28 ( EudraCT Number )
Study First Received: November 28, 2011
Last Updated: April 21, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017