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NCT01973049 · ClinicalTrials.gov registry record · Phase 3
UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 202
- Enrollment target
NCT01973049: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01973049 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 202 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01973049, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 202 participants
- Enrollment target
Study Summary
To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.
Primary Outcome
SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) \< Limit of Quantification (LOQ) target detected or target not detected (LOQ TD/TND)
Interventions
- DRUG Ribavirin
- DRUG Daclatasvir
- DRUG BMS-791325
- DRUG Asunaprevir
- DRUG Placebo matching Ribavirin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT01973049 record still lists
NCT01973049 is an interventional study that assigns participants to a tested intervention. The registered 202 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 (74% lower).
The record links to 0 conditions, and to 5 interventions - of which Ribavirin is the first listed.
NCT01973049 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01973049 about?
NCT01973049 is a clinical study titled "UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis". To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.
What is the current status of trial NCT01973049?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 202 participants. The study started on 2013-12. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01973049?
The interventions under investigation include: Ribavirin (DRUG), Daclatasvir (DRUG), BMS-791325 (DRUG), Asunaprevir (DRUG), Placebo matching Ribavirin (DRUG).
Who is sponsoring clinical trial NCT01973049?
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 NCT01973049's enrollment target sits among peer trials
202 1353rd of 2000 higher than 648 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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