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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 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 748 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01581203
The ClinicalTrials.gov registry entry for NCT01581203 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 748 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ribavirin (RBV) is the first listed.
NCT01581203 reports 0 study locations.
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.
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