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NCT00882908 · ClinicalTrials.gov registry record · Phase 2
A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment
A Phase 2 study, sponsored by Tibotec Pharmaceuticals, Ireland.
- Completed
- Registry status
- Phase 2
- Development phase
- 386
- Enrollment target
NCT00882908: Completed Phase 2 study, sponsored by Tibotec Pharmaceuticals, Ireland.
NCT00882908 is a Phase 2 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 386 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (190% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00882908, a Phase 2 study, has completed, sponsored by Tibotec Pharmaceuticals, Ireland.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 386 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA \[less than 25 IU per mL undetectable\] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.
Primary Outcome
The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.
Interventions
- DRUG Placebo
- DRUG TMC435
- DRUG Ribavirin (R)
- DRUG PegIFNα-2a (P)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 386 participants |
| Start Date | 2009-06 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
What the finished NCT00882908 record still lists
NCT00882908 is an interventional study that assigns participants to a tested intervention. The registered 386 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (190% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00882908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00882908 about?
NCT00882908 is a clinical study titled "A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment". The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA \[less tha...
What is the current status of trial NCT00882908?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 386 participants. The study started on 2009-06. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00882908?
The interventions under investigation include: Placebo (DRUG), TMC435 (DRUG), Ribavirin (R) (DRUG), PegIFNα-2a (P) (DRUG).
Who is sponsoring clinical trial NCT00882908?
This trial is sponsored by Tibotec Pharmaceuticals, Ireland, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00882908's enrollment target sits among peer trials
386 109th of 2000 higher than 1,892 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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