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: Chronic Hepatitis C
• Interventions: Drug: SCV-07

• Registration Number: NCT01310205
• Lead Sponsor: SciClone Pharmaceuticals

Brief Summary

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.

Detailed Description

In this extension study, subjects will be asked to give permission to share their HCV RNA viral load test results, obtained from local laboratories, at the different time points and will also be asked to give permission to share their SOC dosing information (peg-IFN and RBV). As no SCV-07 treatment, procedures, or assessments will be required during this extension study, no related safety information will be collected.

The study will last up to 72 weeks after subjects complete treatment on study SCI-SCV-HCV-P2-001 and begin retreatment with peg-IFN and RBV.

Study Timeline

• Study Start: 2010-08
• Status Verified: 2011-03
• Study First Submitted: 2011-03-04
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-08
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatitis C treatment	SCV-07	This is an extension of ongoing study SCI-SCV-HCV-P2-001. 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
non cirrhotic subjects	SCV-07	This is an extension of ongoing study SCI-SCV-HCV-P2-001. 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

Trial Locations

Locations (4)

Univ of Louisville Med/Dental Complex; 🇺🇸 Louisville, Kentucky, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, Washington, United States

AGMG Clinical Research; 🇺🇸 Anaheim, California, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States