TMC435-TiDP16-C205: A Phase II Study of TMC435 in Combination With Pegylated Interferon Alpha-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment


Tracking Information

Start Date  ICMJEMay 2009
Estimated Primary Completion DateApril 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2009)
The primary objective of the trial is to evaluate the efficacy of 4 different regimens of TMC435 in combination with SoC, defined as the proportion of patients with undetectable HCV RNA (< 10 IU/mL) 24 weeks after the planned end of treatment. [ Time Frame: 24 weeks after the planned end of treatment. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00882908 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: April 16, 2009)
  • Evaluate TMC435 antiviral activity [ Time Frame: every study visit ] [ Designated as safety issue: No ]
  • Evaluate TMC435 safety [ Time Frame: every study visit ] [ Designated as safety issue: No ]
  • Evaluate TMC435 tolerability [ Time Frame: every study visit ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJETMC435-TiDP16-C205: A Phase II Study of TMC435 in Combination With Pegylated Interferon Alpha-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment
Official Title  ICMJEA Phase IIb, Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferonalfa-2a and Ribavirin in Treatment-na�ve Genotype 1hepatitis C-infected Subjects.
Brief Summary

The purpose of this study is to test the efficacy, safety and tolerability of 4 different regimens of TMC435 given in combination with Peginterferon alfa-2a and ribaviron (Standard of Care) as compared to placebo + Standard of Care.

Detailed Description

The study is a randomized (study drug assigned by chance), 5-arm, double-blind (neither patient nor physician know the assigned drug name), placebo-controlled trial to compare the efficacy, tolerability and safety of different TMC435 regimens combined with the standard of care (SoC: peginterferon alfa-2a and ribavirin) versus SoC alone in adult treatment-naïve patients (never received treatment for HCV) with chronic genotype 1 hepatitis C virus (HCV) infection. Depending on the treatment arm, patients will receive TMC435 (75 or 150 mg) or placebo capsules for a duration of 12 or 24 weeks. In treatment arms 1 and 2, subjects will receive 12 weeks of triple therapy with TMC435 once daily plus SoC followed by 12 weeks of treatment with SoC plus TMC435-matched placebo. In treatment arms 3 and 4, patients will receive 24 weeks of triple therapy with TMC435 once daily plus SoC. In treatment arm 5 (control group), patients will be treated with SoC treatment for 48 weeks and TMC435-matched placebo for the first 24 weeks. Pegylated interferon is given as a pre-filled syringe containing 0.5 mL solution with 180 µg PegIFNalpha-2a, to be injected under the skin once weekly. 1000-1200mg of Ribavirin, given as 200mg tablets, is taken twice a day with food. The study's objective is to evaluate and compare the efficacy of the treatment arms including TMC435 vs the SoC arm by measuring the proportion of patients with undetectable HCV RNA (< 10 IU/mL) 24 weeks after the planned end of treatment. TMC435 is a 75mg capsule and will be taken orally (via the mouth). Depending on the treatment arm patients will receive TMC435 or placebo for a duration of 12 or 24 weeks. The Standard of Care (SoC) treatment will last 24 or 48 weeks: Pegylated interferon is given as a pre-filled syringe containing 0.5 mL solution with 180 µg pegINFalpha-2a, to be injected under the skin once weekly. Ribavirin is given as 200 mg tablets (daily dose: 1000-1200mg), and taken orally two times a day with food.

Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Condition  ICMJEHepatitis C
Intervention  ICMJE
  • Drug: Ribavirin PegIFNalpha-2a
    1000-1200mg tab twice a day for 24wks Weekly 180µg injection for 24wks
  • Drug: TMC435 Ribavirin
    150mg tab/day for 24 wks 1000-1200mg tab twice a day for 24wks
  • Drug: PegIFNalpha-2a
    Weekly 180µg injection for 24wks
  • Drug: TMC435 TMC435 Placebo
    150mg tab/day for 12 wks Placebo tab/day for 12 wks
  • Drug: PegIFNalpha-2a
    Weekly 180µg injection for 48wks
  • Drug: TMC435 Ribavirin
    75mg tab/day for 24 wks 1000-1200mg tab twice a day for 24wks
  • Drug: TMC435 Placebo Ribavirin
    Placebo tab/day for 24 wks 1000-1200mg tab twice/day for 48 wks
  • Drug: TMC435 TMC435 Placebo
    75mg tab/day for 12wks Placebo tab/day for 12wks
Study Arms / Comparison Groups
  • 001: Experimental

    Ribavirin

    PegIFNalpha-2a 1000-1200mg tab twice a day for 24wks Weekly 180µg injection for 24wks,TMC435 TMC435 Placebo 75mg tab/day for 12wks Placebo tab/day for 12wks

    Interventions:
    • Drug: Ribavirin PegIFNalpha-2a
    • Drug: TMC435 TMC435 Placebo
  • 002: Experimental

    Ribavirin

    PegIFNalpha-2a 1000-1200mg tab twice a day for 24wks Weekly 180µg injection for 24wks,TMC435 TMC435 Placebo 150mg tab/day for 12 wks Placebo tab/day for 12 wks

    Interventions:
    • Drug: Ribavirin PegIFNalpha-2a
    • Drug: TMC435 TMC435 Placebo
  • 003: Experimental
    PegIFNalpha-2a Weekly 180µg injection for 24wks,TMC435 Ribavirin 75mg tab/day for 24 wks 1000-1200mg tab twice a day for 24wks
    Interventions:
    • Drug: PegIFNalpha-2a
    • Drug: TMC435 Ribavirin
  • 004: Experimental
    PegIFNalpha-2a Weekly 180µg injection for 24wks,TMC435 Ribavirin 150mg tab/day for 24 wks 1000-1200mg tab twice a day for 24wks
    Interventions:
    • Drug: TMC435 Ribavirin
    • Drug: PegIFNalpha-2a
  • 005: Active Comparator
    PegIFNalpha-2a Weekly 180µg injection for 48wks,TMC435 Placebo Ribavirin Placebo tab/day for 24 wks 1000-1200mg tab twice/day for 48 wks
    Interventions:
    • Drug: PegIFNalpha-2a
    • Drug: TMC435 Placebo Ribavirin

Recruitment Information

Estimated Enrollment  ICMJE400
Estimated Completion DateApril 2011
Estimated Primary Completion DateApril 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with documented chronic genotype-1 hepatitis C infection and with plasma HCV RNA of > 100,000 IU/mL at screening
  • Patients that have not been treated before for HCV
  • Patients that are of childbearing potential or have a partner of childbearing potential should agree to use 2 effective methods of contraception.

Exclusion Criteria:

  • Patients with cirrhosis or evidence of hepatic decompensation
  • Co-infection with the human immunodeficiency virus (HIV)
  • Any contraindication to Pegasys or Copegus therapy
  • History of, or any current medical condition which could impact the safety of the patient in the study.
GenderBoth
Ages18 Years to 70 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:info1@veritasmedicine.com
Location Countries  ICMJEUnited States,   Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   New Zealand,   Norway,   Poland,   Russian Federation,   Spain

Administrative Information

NCT ID  ICMJENCT00882908
Responsible PartyClinical Development Team Leader, Tibotec Pharmaceuticals, Ireland
Study ID Numbers  ICMJECR015799
Study Sponsor  ICMJETibotec Pharmaceuticals, Ireland
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Tibotec Pharmaceuticals Clinical TrialTibotec Pharmaceuticals
Information Provided ByTibotec Pharmaceuticals, Ireland