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

This study has been completed.
Sponsor:
Information provided by:
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00980330
First received: September 10, 2009
Last updated: April 27, 2012
Last verified: April 2012
History of Changes

September 10, 2009
April 27, 2012
September 2009
February 2011   (final data collection date for primary outcome measure)
The proportion of patients with undetectable HCV RNA [ 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 NCT00980330 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
TMC435-TiDP16-C206: A Safety and Efficacy Study in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard 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 PegIFNa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Failed Previous Standard Therapy

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).

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.
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: 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
    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 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
  • Drug: TMC435 /Peg IFNa2A/Ribavirin
    48 weeks 150 mg TMC435 /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
  • 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
    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
  • Experimental: 004
    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
  • Experimental: 005
    TMC435 /Peg IFNa2A/Ribavirin 48 weeks 100 mg TMC435 /180µg injection Peg IFNa2A/1000-1200 mg Ribavirin
    Interventions:
    • Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
    • Drug: TMC435 /Peg IFNa2A/Ribavirin
  • Experimental: 006
    TMC435 /Peg IFNa2A/Ribavirin 48 weeks 150 mg TMC435 /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
    Interventions:
    • Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
    • Drug: TMC435 /Peg IFNa2A/Ribavirin
  • Active Comparator: 007
    TMC435 placebo /Peg IFNa2A/Ribavirin 48 weeks TMC435 placebo /180 µg injection Peg IFNa2A/1000-1200 mg Ribavirin
    Interventions:
    • Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
    • Drug: TMC435 placebo /Peg IFNa2A/Ribavirin
  • Experimental: 001
    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
    Interventions:
    • Drug: TMC435 /Peg IFNa2A/Ribavirin
    • Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
  • Experimental: 002
    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
    Interventions:
    • Drug: TMC435 /Peg IFNa2A/Ribavirin
    • Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
  • Experimental: 003
    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
    Interventions:
    • Drug: TMC435 placebo /Peg IFNa2A/Ribavirin
    • Drug: TMC435 /Peg IFNa2A/Ribavirin TMC435 placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
464
August 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Israel,   New Zealand,   Norway,   Poland,   Portugal,   Russian Federation,   United Kingdom
 
NCT00980330
CR016063, TMC435-TiDP16-C206
Yes
Compound Development Team Leader, Tibotec Pharmaceuticals, Ireland
Tibotec Pharmaceuticals, Ireland
Not Provided
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
Tibotec Pharmaceuticals, Ireland
April 2012

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