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NCT00446134 · ClinicalTrials.gov registry record · Phase 2
Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)
A Phase 2 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 2
- Development phase
- 278
- Enrollment target
NCT00446134: Completed Phase 2 study, sponsored by Bausch Health Americas.
NCT00446134 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 278 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (109% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00446134, a Phase 2 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 278 participants
- Enrollment target
Study Summary
The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic Hepatitis C Virus (HCV) genotype 1 infection.
Primary Outcome
The primary efficacy endpoint was the numbers of responders at Treatment Week (TW) 12. Responders are defined as patients achieving either viral negativity or a partial response (PR). Viral negativity is defined as \<100 copies/mL serum HCV RNA. A PR is defined as \< 100 copies/mL serum HCV RNA and at least a 2-log decrease from baseline in serum HCV RNA levels. Responder rates with corresponding 95% confidence intervals were estimated for each treatment group.
Interventions
- DRUG Ribavirin
- DRUG Taribavirin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
What the finished NCT00446134 record still lists
NCT00446134 is an interventional study that assigns participants to a tested intervention. The registered 278 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 (109% higher).
The record links to 0 conditions, and to 2 interventions - of which Ribavirin is the first listed.
NCT00446134 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00446134 about?
NCT00446134 is a clinical study titled "Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)". The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive p...
What is the current status of trial NCT00446134?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 278 participants. The study started on 2007-03. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00446134?
The interventions under investigation include: Ribavirin (DRUG), Taribavirin (DRUG).
Who is sponsoring clinical trial NCT00446134?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00446134's enrollment target sits among peer trials
278 202nd of 2000 higher than 1,799 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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