A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects
Completed · Phase 2 · Has a placebo group
Conditions studied: Chronic Hepatitis C
In brief
The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection
Key facts
- Study ID
- NCT00722358
- Run by
- Bristol-Myers Squibb
- People needed
- 15
- Starts
- 2008-12-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2011-06-27
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Chronically infected with HCV genotype 1
- Treatment naive
- HCV RNA viral load of ≥10*5 IU/mL
- BMI 18 to 35kg/m²
You may not qualify if…
- Women of childbearing potential (WOCBP)
- Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
- HCV infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of SOC and continue to have a detectable HCV RNA level or subjects who did not attain a 2-log decline in HCV RNA levels at 12 weeks and stopped treatment
- HCV infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of SOC due to toxicities associated with interferon and/or ribavirin
- HIV and/or HBV positive
- Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
Where it is running
- Advanced Clinical Res Inst — Anaheim, California, United States
- Orlando Clinical Research Center — Orlando, Florida, United States
- Parexel International Corporation — Baltimore, Maryland, United States
- Central Texas Clinical Research — Austin, Texas, United States
- Local Institution — Santurce, Puerto Rico
Full record on ClinicalTrials.gov
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