Text Size

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 (PILLAR)

This study has been completed.
Sponsor:
Information provided by:
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00882908
First received: April 16, 2009
Last updated: June 28, 2012
Last verified: June 2012
History of Changes

April 16, 2009
June 28, 2012
May 2009
April 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00882908 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
A 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-naive Genotype 1hepatitis C-infected Subjects.

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hepatitis C
  • Drug: Ribavirin PegIFNalpha-2a
    1000-1200mg tab twice a day for 24wks Weekly 180µg injection for 24wks
  • Drug: TMC435 Ribavirin
    75mg tab/day for 24 wks 1000-1200mg tab twice a day for 24wks
  • Drug: PegIFNalpha-2a
    Weekly 180µg injection for 48wks
  • 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: TMC435 Ribavirin
    150mg 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
  • Experimental: 001

    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
  • Experimental: 002

    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
  • Experimental: 003
    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: TMC435 Ribavirin
    • Drug: PegIFNalpha-2a
  • Experimental: 004
    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
  • Active Comparator: 005
    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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
386
April 2011
April 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   New Zealand,   Norway,   Poland,   Russian Federation,   Spain
 
NCT00882908
CR015799
Yes
Clinical Development Team Leader, Tibotec Pharmaceuticals, Ireland
Tibotec Pharmaceuticals, Ireland
Not Provided
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
Tibotec Pharmaceuticals, Ireland
June 2012

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