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NCT00980330 · ClinicalTrials.gov registry record · Phase 2
A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment
A Phase 2 study, sponsored by Tibotec Pharmaceuticals, Ireland.
- Completed
- Registry status
- Phase 2
- Development phase
- 463
- Enrollment target
NCT00980330: Completed Phase 2 study, sponsored by Tibotec Pharmaceuticals, Ireland.
NCT00980330 is a Phase 2 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 463 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (248% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00980330, a Phase 2 study, has completed, sponsored by Tibotec Pharmaceuticals, Ireland.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 463 participants
- Enrollment target
Study 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 participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).
Primary Outcome
The table below shows the percentage of participants in the overall population with an SVR24, defined as having plasma levels of Hepatitis C Virus ribonucleic acid less than 25 IU/mL undetectable at the EOT and 24 weeks after the EOT.
Interventions
- DRUG Placebo
- DRUG TMC435
- DRUG Ribavirin (R)
- DRUG Peg-IFN-alfa-2a (P)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 463 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT00980330 record still lists
NCT00980330 is an interventional study that assigns participants to a tested intervention. The registered 463 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 (248% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00980330 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00980330 about?
NCT00980330 is a clinical study titled "A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment". 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 participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated in...
What is the current status of trial NCT00980330?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 463 participants. The study started on 2009-10. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00980330?
The interventions under investigation include: Placebo (DRUG), TMC435 (DRUG), Ribavirin (R) (DRUG), Peg-IFN-alfa-2a (P) (DRUG).
Who is sponsoring clinical trial NCT00980330?
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 NCT00980330's enrollment target sits among peer trials
463 82nd of 2000 higher than 1,919 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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