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NCT01628692 · ClinicalTrials.gov registry record · Phase 2
Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 230
- Enrollment target
NCT01628692: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT01628692 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 230 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01628692, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 230 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.
Primary Outcome
SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be \<lower limit of quantitation, target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Interventions
- DRUG Ribavirin
- DRUG Daclatasvir
- DRUG Simeprevir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
What the finished NCT01628692 record still lists
NCT01628692 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% higher).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT01628692 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01628692 about?
NCT01628692 is a clinical study titled "Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus". The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.
What is the current status of trial NCT01628692?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 230 participants. The study started on 2012-07. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01628692?
The interventions under investigation include: Ribavirin (DRUG), Daclatasvir (DRUG), Simeprevir (DRUG).
Who is sponsoring clinical trial NCT01628692?
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 NCT01628692's enrollment target sits among peer trials
230 257th of 2000 higher than 1,737 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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