Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed
- Registration Number
- NCT00968357
- Lead Sponsor
- SciClone Pharmaceuticals
- Brief Summary
SCV-07 (γ-D-glutamyl-L-tryptophan) is a new immunomodulatory compound that has been developed and patented both for composition and immunomodulatory use and is a synthetic dipeptide. The efficacy of SCV 07 in treating chronic hepatitis C virus (HCV) infection is expected to arise from the drug's ability to stimulate the T-helper 1 (Th1) type immune response and to block signal transducers and activator of transcription 3 (STAT3) mediated signaling. The purpose of this study is to determine if SCV-07 alone and/or SCV-07 in combination with ribavirin is safe and potentially effective for the treatment of genotype 1 compensated chronic hepatitis C in subjects who have relapsed after a response to a previous treatment course of at least 44 weeks with pegylated interferon and ribavirin. All subjects will receive 4 weeks of SCV-07 (Lead-in Phase), followed by 4 weeks of treatment with SCV-07 in combination with ribavirin (Combination Treatment).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Adult subjects must have compensated liver disease
- Subjects must have a history of chronic hepatitis C (genotype 1), and must be relapsers
- Subject's HCV RNA viral load must be > or = 300,000 IU/mL
- Subjects must have documentation of a liver biopsy within the last 2 years
- Human immunodeficiency virus (HIV) infection or hepatitis B surface antigen (HBsAg)-positive
- Clinical evidence of cirrhosis
- Autoimmune hepatitis or other autoimmune/immune-active diseases
- Insulin-dependent diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SCV-07 SCV-07 Cohort 1: SCV-07 0.1 mg/kg. Cohort 2: 1.0 mg/kg per day administered SC
- Primary Outcome Measures
Name Time Method To assess the safety of SCV-07 at 2 dose levels given as a monotherapy and to assess the immunomodulatory effects of SCV-07 given at 2 dose levels for 4 weeks and in combination with ribavirin for 4 weeks after monotherapy, respectively. 8 weeks
- Secondary Outcome Measures
Name Time Method To assess the pharmacodynamic effects of SCV 07 and the pharmacokinetics as a monotherapy and in combination with ribavirin 8 weeks
Trial Locations
- Locations (16)
AGMG Clinical Research
🇺🇸Anaheim, California, United States
Impact Clinical Trials
🇺🇸Los Angeles, California, United States
A Professional Corporation
🇺🇸Palm Springs, California, United States
Arapahoe Gastroenterology
🇺🇸Littleton, Colorado, United States
Washington Hospital Center-MedStar Research Institute
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Commonwealth Biomedical Research, LLC
🇺🇸Madisonville, Kentucky, United States
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