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NCT00758043 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 540
- Enrollment target
NCT00758043: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT00758043 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 540 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00758043, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 540 participants
- Enrollment target
Study Summary
This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.
Primary Outcome
SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification \[LLOQ\] of 25 IU/mL).
Interventions
- DRUG ribavirin
- DRUG telaprevir
- BIOLOGICAL peginterferon alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2008-10 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
What the finished NCT00758043 record still lists
NCT00758043 is an interventional study that assigns participants to a tested intervention. The registered 540 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 3 interventions - of which ribavirin is the first listed.
NCT00758043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00758043 about?
NCT00758043 is a clinical study titled "A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response". This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative ...
What is the current status of trial NCT00758043?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2008-10. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00758043?
The interventions under investigation include: ribavirin (DRUG), telaprevir (DRUG), peginterferon alfa-2a (BIOLOGICAL).
Who is sponsoring clinical trial NCT00758043?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00758043's enrollment target sits among peer trials
540 694th of 2000 higher than 1,301 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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