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

Completed · Phase 2

Conditions studied: Chronic Hepatitis C

In brief

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).

Key facts

Study ID

NCT00968357

Run by

SciClone Pharmaceuticals

People needed

40

Starts

2009-09-01

Expected to finish

2011-01-01

Last updated by the study team

2012-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 D.C., District of Columbia, United States
• Walter Reed Army Medical Center — Washington D.C., 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
• Paul Thuluvath — Baltimore, Maryland, United States
• Duke University Department of Medicine — Durham, North Carolina, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Vanderbilt Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine (VAMC 15) — Houston, Texas, United States
• Kaiser Permanente — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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