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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
November 28, 2011
April 21, 2017
November 30, 2011
January 31, 2014   (Final data collection date for primary outcome measure)
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) ]
Sustained virological response 12 weeks after treatment (SVR-12) [ Time Frame: up to 60 weeks ]
Complete list of historical versions of study NCT01482390 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Virologic response over time [ Time Frame: 72 weeks ]
  • Proportion of patients who develop treatment resistance [ Time Frame: 72 weeks ]
  • Safety (incidence of adverse events) [ Time Frame: 72 weeks ]
  • Pharmacokinetics (concentration of RO4995855 (parent drug of RO5024048)) [ Time Frame: 24 weeks ]
  • Pharmacokinetics (concentration of telaprevir) [ Time Frame: 24 weeks ]
Not Provided
Not Provided
 
A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Hepatitis C
  • 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.
  • 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).
    Interventions:
    • Drug: Ribavirin
    • Drug: Mericitabine
    • Drug: Peginterferon Alfa-2a
    • Drug: Telaprevir
  • 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).
    Interventions:
    • Drug: Ribavirin
    • Drug: Mericitabine
    • Drug: Peginterferon Alfa-2a
    • Drug: Telaprevir
  • 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).
    Interventions:
    • Drug: Ribavirin
    • Drug: Mericitabine
    • Drug: Peginterferon Alfa-2a
    • Drug: Placebo
    • Drug: Telaprevir
  • 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).
    Interventions:
    • Drug: Ribavirin
    • Drug: Peginterferon Alfa-2a
    • Drug: Placebo
    • Drug: Telaprevir
Wedemeyer H, Forns X, Hézode C, Lee SS, Scalori A, Voulgari A, Le Pogam S, Nájera I, Thommes JA. Mericitabine and Either Boceprevir or Telaprevir in Combination with Peginterferon Alfa-2a plus Ribavirin for Patients with Chronic Hepatitis C Genotype 1 Infection and Prior Null Response: The Randomized DYNAMO 1 and DYNAMO 2 Studies. PLoS One. 2016 Jan 11;11(1):e0145409. doi: 10.1371/journal.pone.0145409. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
January 31, 2014
January 31, 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
 
 
NCT01482390
NV27779
2011-002715-28 ( EudraCT Number )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP