Extension Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Peg-INF and RBV After Completing Treatment in HCV
Completed
Conditions studied: Chronic Hepatitis C
In brief
This is an extension of ongoing study SCI-SCV-HCV-P2-001 in which subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV.
Key facts
- Study ID
- NCT01310205
- Run by
- SciClone Pharmaceuticals
- People needed
- 12
- Starts
- 2010-08-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2012-03-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects who satisfy all of the following criteria may be enrolled into the study:
- Subjects must be able to understand and sign an ICF approved by the investigator's institutional review board (IRB) for this study; must have completed treatment on study SCI-SCV-HCV-P2-001; and must, in the judgment of the investigators, be able to benefit from retreatment per current SOC (peg-IFN and RBV).
You may not qualify if…
- Subjects who satisfy any of the following criteria will not be enrolled into the study:
- Subjects who, in the opinion of the investigators, will be unable to tolerate retreatment with peg-IFN and RBV for at least 48 weeks and are at high risk of early treatment discontinuation and plan to participate in another investigational trial prior to providing a final sample for this trial.
Where it is running
- AGMG Clinical Research — Anaheim, California, United States
- Univ of Louisville Med/Dental Complex — Louisville, Kentucky, United States
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States
- Walter Reed Army Medical Center — Washington, Washington, United States
Full record on ClinicalTrials.gov
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