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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

  Show 39 Study Locations
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 23, 2017