TMC435-TiDP16-C206: A Safety and Efficacy Study in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment 


Tracking Information

Start Date  ICMJESeptember 2009
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2009)		The proportion of patients with undetectable HCV RNA [ 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 NCT00980330 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: September 18, 2009)
  • Proportion of patients with rapid virologic response (RVR) [ Time Frame: at Week 4 ] [ Designated as safety issue: No ]
  • Proportion of patients with early virologic response (EVR) and complete early virologic response (cEVR) [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
  • Proportion of patients with undetectable HCV-RNA (SVR 12) [ Time Frame: at Week 60 ] [ Designated as safety issue: No ]
  • Changes in HCV RNA levels over time [ Time Frame: 20 visits over 72-week period ] [ Designated as safety issue: No ]
  • PK/PD relationship of TMC435 [ Time Frame: at Week 2, 4, 8, 12, 16, 24 and 48 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJETMC435-TiDP16-C206: A Safety and Efficacy Study in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard 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 PegIFNa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Failed Previous Standard Therapy
Brief Summary

The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in patients with chronic, genotype 1, hepatitis C who have failed previous treatment with pegylated interferon (Peg-INF) and ribavirin (RBV).

Detailed Description

The study is a randomized (study drug assigned by chance), double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled Phase IIb trial with TMC435 in patients with chronic, genotype 1, hepatitis C who have failed standard treatment with pegylated interferon (Peg-INF) and ribavirin (RBV). The study will compare the efficacy, tolerability and safety of different regimens with TMC435 combined with standard treatment (Peg-INF and RBV) versus standard treatment alone. The trial will consist of a screening period of maximum 6 weeks, a 48-week treatment period, and a 24-week follow-up period. Patients will be eligible to enroll in the trial if they failed to respond to a prior course of standard treatment or relapsed following standard treatment. Treatment arms 1 and 2 will receive TMC435 with standard treatment for 12 weeks; followed by standard treatment (plus placebo) for 36 weeks. Treatment arms 3 and 4 will receive TMC435 (100 mg or 150 mg once a day) with standard treatment for 24 weeks; followed by standard treatment (plus placebo) for 24 weeks. Treatment arms 5 and 6 will receive TMC435 (100 mg or 150 mg once a day) with standard treatment for 48 weeks. Treatment arm 7 (control arm) will receive standard treatment for 48 weeks. TMC435 (either 100 mg or 150 mg) will be given by mouth once a day for either 12, 24 or 48 weeks. Placebo will be given by mouth once a day for either 24, 36 or 48 weeks. Peg-INF will be given as an injection under the skin at a dose of 180 mcg once every week for 48 weeks. RBV (either 1000 or 1200 mg, depending on your body weight) will be given by mouth twice a day for 48 weeks.

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: TMC435 placebo /Peg IFNa2A/Ribavirin
    48 weeks TMC435 placebo /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
  • Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
    24 weeks 150 mg TMC435 / 180 µg injection Peg IFNa2A/ 1000-1200 mg Ribavirin followed by 24 weeks TMC435 placebo /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
  • Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
    12 weeks 100 mg TMC435 / 180 µg injection Peg IFNa2A/ 1000-1200 mg Ribavirin followed by 36 weeks TMC435 placebo /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
  • Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
    24 weeks 100 mg TMC435 / 180 µg injection Peg IFNa2A/ 1000-1200 mg Ribavirin followed by 24 weeks TMC435 placebo /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
  • Drug: TMC435 /Peg IFNa2A/Ribavirin
    48 weeks 100 mg TMC435 /180µg injection Peg IFNa2A/1000-1200 mg Ribavirin
  • Drug: TMC435 /Peg IFNa2A/Ribavirin
    48 weeks 150 mg TMC435 /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
  • Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
    12 weeks 150 mg TMC435 / 180 µg injection Peg IFNa2A/ 1000-1200 mg Ribavirin followed by 36 weeks TMC435 placebo /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
Study Arms / Comparison Groups
  • 001: Experimental
    TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo 12 weeks 100 mg TMC435 / 180 µg injection Peg IFNa2A/ 1000-1200 mg Ribavirin followed by 36 weeks TMC435 placebo /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
    Intervention: Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
  • 002: Experimental
    TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo 12 weeks 150 mg TMC435 / 180 µg injection Peg IFNa2A/ 1000-1200 mg Ribavirin followed by 36 weeks TMC435 placebo /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
    Intervention: Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
  • 003: Experimental
    TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo 24 weeks 100 mg TMC435 / 180 µg injection Peg IFNa2A/ 1000-1200 mg Ribavirin followed by 24 weeks TMC435 placebo /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
    Intervention: Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
  • 004: Experimental
    TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo 24 weeks 150 mg TMC435 / 180 µg injection Peg IFNa2A/ 1000-1200 mg Ribavirin followed by 24 weeks TMC435 placebo /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
    Intervention: Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
  • 005: Experimental
    TMC435 /Peg IFNa2A/Ribavirin 48 weeks 100 mg TMC435 /180µg injection Peg IFNa2A/1000-1200 mg Ribavirin
    Intervention: Drug: TMC435 /Peg IFNa2A/Ribavirin
  • 006: Experimental
    TMC435 /Peg IFNa2A/Ribavirin 48 weeks 150 mg TMC435 /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
    Intervention: Drug: TMC435 /Peg IFNa2A/Ribavirin
  • 007: Active Comparator
    TMC435 placebo /Peg IFNa2A/Ribavirin 48 weeks TMC435 placebo /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
    Intervention: Drug: TMC435 placebo /Peg IFNa2A/Ribavirin

Recruitment Information

Estimated Enrollment  ICMJE455
Estimated Completion DateJuly 2011
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level >= 10000 IU/mL
  • Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)
  • Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

Exclusion Criteria:

  • Co-infection with any other Hepatitis C virus genotype or co-infection with the human immunodeficiency virus (HIV)
  • Evidence of decompensated liver disease
  • Patient has a medical condition which is a contraindication to Peg-INF or RBV 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,   France,   Germany,   Israel,   New Zealand,   Norway,   Poland,   Portugal,   Russian Federation,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00980330
Responsible PartyCompound Development Team Leader, Tibotec Pharmaceuticals, Ireland
Study ID Numbers  ICMJECR016063, TMC435-TiDP16-C206
Study Sponsor  ICMJETibotec Pharmaceuticals, Ireland
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Tibotec Pharmaceuticals Clinical TrialTibotec Pharmaceuticals
Information Provided ByTibotec Pharmaceuticals, Ireland