Status:
COMPLETED
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
Lead Sponsor:
SciClone Pharmaceuticals
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 S...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00968357
Start Date
September 1 2009
End Date
January 1 2011
Last Update
June 8 2012
Active Locations (16)
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1
AGMG Clinical Research
Anaheim, California, United States, 92803
2
Impact Clinical Trials
Los Angeles, California, United States, 90036
3
A Professional Corporation
Palm Springs, California, United States, 92262
4
Arapahoe Gastroenterology
Littleton, Colorado, United States, 80120