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NCT01459913 · ClinicalTrials.gov registry record · Phase 3
Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Terminated
- Registry status
- Phase 3
- Development phase
- 239
- Enrollment target
NCT01459913: Clinical Trial Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT01459913 is a Phase 3 study that was terminated before completion, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 239 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01459913, a Phase 3 study, was terminated before completion, sponsored by Vertex Pharmaceuticals Incorporated.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 239 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.
Primary Outcome
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV
Interventions
- DRUG Ribavirin
- DRUG Telaprevir
- DRUG Pegylated Interferon Alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
Why NCT01459913 stopped before completion
NCT01459913 is an interventional study that assigns participants to a tested intervention. The registered 239 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 (69% lower).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT01459913 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01459913 about?
NCT01459913 is a clinical study titled "Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype". The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study ...
What is the current status of trial NCT01459913?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 239 participants. The study started on 2011-11. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01459913?
The interventions under investigation include: Ribavirin (DRUG), Telaprevir (DRUG), Pegylated Interferon Alfa-2a (DRUG).
Who is sponsoring clinical trial NCT01459913?
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 NCT01459913's enrollment target sits among peer trials
239 1291st of 2000 higher than 710 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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