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NCT01125189 · ClinicalTrials.gov registry record · Phase 2
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 558
- Enrollment target
NCT01125189 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 558 participants.
The verdict
NCT01125189, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 558 participants
- Enrollment target
Study Summary
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.
Interventions
- DRUG Placebo
- DRUG Daclatasvir
- DRUG ribavirin
- DRUG peg-interferon alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01125189
The ClinicalTrials.gov registry entry for NCT01125189 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 558 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 Placebo is the first listed.
NCT01125189 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01125189 about?
NCT01125189 is a clinical study titled "Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients". To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.
What is the current status of trial NCT01125189?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 558 participants. The study started on 2010-07. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01125189?
The interventions under investigation include: Placebo (DRUG), Daclatasvir (DRUG), ribavirin (DRUG), peg-interferon alfa-2a (DRUG).
Who is sponsoring clinical trial NCT01125189?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
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