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NCT00546715 · ClinicalTrials.gov registry record · Phase 1
A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects
A Phase 1 study of Chronic Hepatitis C, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
- 7
- Study locations
NCT00546715: Completed Phase 1 study of Chronic Hepatitis C, sponsored by Bristol-Myers Squibb.
NCT00546715 is a Phase 1 study of Chronic Hepatitis C that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 95 participants, below the 208-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (54% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00546715, a Phase 1 study of Chronic Hepatitis C, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
- 7
- Study locations
Study Summary
The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis C infection
Primary Outcome
AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding) or disease which either occurs during study, whether or not related to the study drug. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investig
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Daclatasvir
Study Locations (7)
California
- Advanced Clinical Research Institute - Anaheim
Florida
- Orlando Clinical Research Center - Orlando
Maryland
- Parexel International Corporation - Baltimore
Minnesota
- Mayo Clinic - Rochester
New Jersey
- Bristol-Myers Squibb Clinical Pharmacology Unit - Hamilton
Pennsylvania
- Thomas Jefferson University - Philadelphia
Virginia
- University Of Virginia Digestive Health Center Of Excellence - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-05 |
| Phase | Phase 1 |
What the finished NCT00546715 record still lists
NCT00546715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 208-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Chronic Hepatitis C appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00546715 lists 7 locations in 7 states (California, Florida, Maryland).
Frequently Asked Questions
What is clinical trial NCT00546715 about?
NCT00546715 is a clinical study titled "A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects". The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis C infection
What is the current status of trial NCT00546715?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2007-11. Estimated completion is 2008-05.
What conditions does trial NCT00546715 study?
This clinical trial studies the following conditions: Chronic Hepatitis C.
What interventions are being tested in trial NCT00546715?
The interventions under investigation include: Placebo (DRUG), Daclatasvir (DRUG).
Who is sponsoring clinical trial NCT00546715?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00546715 being conducted?
This trial has 7 study locations across California, Florida, Maryland, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Hepatitis C
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00546715's enrollment target sits among peer trials
95 6th of 16 higher than 11 of 16 other Chronic Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Hepatitis C 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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