Tracking Information
| Start Date ICMJE | May 2009 |
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| Estimated Primary Completion Date | April 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 ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00882908 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE (submitted: April 16, 2009) |
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| Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
| Brief Title ICMJE | 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 |
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| Official Title ICMJE | 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-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 Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Condition ICMJE | Hepatitis C |
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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Recruitment Information
| Estimated Enrollment ICMJE | 400 | ||||
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| Estimated Completion Date | April 2011 | ||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, New Zealand, Norway, Poland, Russian Federation, Spain |
Administrative Information
| NCT ID ICMJE | NCT00882908 | ||||
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| Responsible Party | Clinical Development Team Leader, Tibotec Pharmaceuticals, Ireland | ||||
| Study ID Numbers ICMJE | CR015799 | ||||
| Study Sponsor ICMJE | Tibotec Pharmaceuticals, Ireland | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Tibotec Pharmaceuticals, Ireland |