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NCT01455090 · ClinicalTrials.gov registry record · Phase 2
Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications
A Phase 2 study of Chronic Hepatitis C, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 320
- Enrollment target
- 20
- Study locations
NCT01455090: Completed Phase 2 study of Chronic Hepatitis C, sponsored by Bristol-Myers Squibb.
NCT01455090 is a Phase 2 study of Chronic Hepatitis C that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 320 participants, above the 194-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (65% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01455090, a Phase 2 study of Chronic Hepatitis C, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 320 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA \< LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 \& Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin
Conditions Studied
Interventions
- DRUG Ribavirin
- DRUG BMS-790052
- DRUG BMS-650032
- DRUG BMS-791325
Study Locations (20)
California
- Southern California Research Center - Coronado
- Peter J Ruane Md Inc - Los Angeles
- Va Greater Los Angeles Healthcare System - Los Angeles
- Research And Education, Inc. - San Diego
- Precision Research Institute, Llc - San Diego
- Medical Associates Research Group - San Diego
Florida
- Orlando Immunology Center - Orlando
- Miami Research Associates - South Miami
Maryland
- Mercy Medical Center, Inc. - Baltimore
- Johns Hopkins University - Lutherville
Oklahoma
- Options Health Research, Llc - Tulsa
- Healthcare Research Consultants - Tulsa
Alabama
- The Kirklin Clinic - Birmingham
Colorado
- University Of Colorado Denver And Hospital - Aurora
District of Columbia
- Medstar Georgetown University Hospital - Washington D.C.
Georgia
- Atlanta Gastroenterology Associates, Llc - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2011-11-30 |
| Est. Completion | 2015-07-31 |
| Phase | Phase 2 |
What the finished NCT01455090 record still lists
NCT01455090 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, above the 194-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (65% higher).
The record links to 1 condition, with Chronic Hepatitis C appearing as the primary indexed condition, and to 4 interventions - of which Ribavirin is the first listed.
NCT01455090 names 20 study sites across 12 states, led by California, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT01455090 about?
NCT01455090 is a clinical study titled "Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications". The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA \< LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 \& Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null r...
What is the current status of trial NCT01455090?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2011-11-30. Estimated completion is 2015-07-31.
What conditions does trial NCT01455090 study?
This clinical trial studies the following conditions: Chronic Hepatitis C.
What interventions are being tested in trial NCT01455090?
The interventions under investigation include: Ribavirin (DRUG), BMS-790052 (DRUG), BMS-650032 (DRUG), BMS-791325 (DRUG).
Who is sponsoring clinical trial NCT01455090?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01455090 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. 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 NCT01455090's enrollment target sits among peer trials
320 4th of 16 higher than 13 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.
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