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NCT01581203 · ClinicalTrials.gov registry record · Phase 3
Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 748
- Enrollment target
NCT01581203: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01581203 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 748 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01581203, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 748 participants
- Enrollment target
Study Summary
The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.
Interventions
- DRUG Ribavirin (RBV)
- DRUG Asunaprevir (ASV)
- DRUG Daclatasvir (DCV)
- DRUG Pegylated-interferon alfa 2a (PegIFN)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 748 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT01581203 record still lists
NCT01581203 is an interventional study that assigns participants to a tested intervention. The registered 748 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Ribavirin (RBV) is the first listed.
NCT01581203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01581203 about?
NCT01581203 is a clinical study titled "Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)". The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are...
What is the current status of trial NCT01581203?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 748 participants. The study started on 2012-05. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01581203?
The interventions under investigation include: Ribavirin (RBV) (DRUG), Asunaprevir (ASV) (DRUG), Daclatasvir (DCV) (DRUG), Pegylated-interferon alfa 2a (PegIFN) (DRUG).
Who is sponsoring clinical trial NCT01581203?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01581203's enrollment target sits among peer trials
748 472nd of 2000 higher than 1,529 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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