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

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.

Official Title

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

Conditions

• Hepatitis C

Study Type

Interventional

Study Design

Treatment, Randomised, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Further Details

Primary outcome measures

• 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 ]

Secondary outcome measures

• 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 ]

Study arms and assigned interventions

1. Experimental:
   • Drug: TMC435 TMC435 Placebo 75mg tab/day for 12wks Placebo tab/day for 12wks
   • Drug: Ribavirin PegIFNalpha-2a 1000-1200mg tab twice a day for 24wks Weekly 180 µg injection for 24wks
2. Experimental: 
   • Drug: Ribavirin PegIFNalpha-2a 1000-1200mg tab twice a day for 24wks Weekly 180 µg injection for 24wks
   • Drug: TMC435 TMC435 Placebo 150mg tab/day for 12 wks Placebo tab/day for 12 wks
3. Experimental:
   • Drug: PegIFNalpha-2a Weekly 180µg injection for 24wks
   • Drug: TMC435 Ribavirin 75mg tab/day for 24 wks 1000-1200mg tab twice a day for 24wks
4. Experimental:
   • Drug: PegIFNalpha-2a Weekly 180µg injection for 24wks
   • Drug: TMC435 Ribavirin 150mg tab/day for 24 wks 1000-1200mg tab twice a day for 24wks
5. Active comparator:
   • Drug: TMC435 Placebo Ribavirin Placebo tab/day for 24 wks 1000-1200mg tab twice/day for 48 wks
   • Drug: PegIFNalpha-2a Weekly 180µg injection for 48wks

Study Start

May 2009-April 2011

Eligibility & Criteria

• Ages eligible for study: 18 years to 70 years
• Genders eligible for study: Both
• Accepts healthy volunteers: No

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.

Total Enrolment

400

Contact Details

info1@veritasmedicine.com