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NCT01389323 · ClinicalTrials.gov registry record · Phase 3
BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 448
- Enrollment target
NCT01389323: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01389323 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 448 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01389323, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 448 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.
Primary Outcome
SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \<lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Interventions
- DRUG Ribavirin
- DRUG Daclatasvir
- DRUG Peg-Interferon Alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 448 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01389323 record still lists
NCT01389323 is an interventional study that assigns participants to a tested intervention. The registered 448 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 (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT01389323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01389323 about?
NCT01389323 is a clinical study titled "BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C". The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.
What is the current status of trial NCT01389323?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 448 participants. The study started on 2011-09. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01389323?
The interventions under investigation include: Ribavirin (DRUG), Daclatasvir (DRUG), Peg-Interferon Alfa-2a (DRUG).
Who is sponsoring clinical trial NCT01389323?
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 NCT01389323's enrollment target sits among peer trials
448 864th of 2000 higher than 1,137 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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