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

SciClone Pharmaceuticals40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C

Interventions

SCV-07 dosage will remain the same throughout the study for each cohort. Monotherapy Lead-in Phase Treatment (SCV-07) for 4 weeks. Combination Treatment (SCV-07 and ribavirin) for 4 weeks, following "Lead-in Phase". Re-treatment with peg INF and RBV will be offered in the "Follow-up" to patients who in the opinion of the investigator may benefit from treatment. All patients will have a total of 3 follow-up visits for safety assessments. Women of childbearing potential will be followed up monthly for approximately up to 6 months after the "end of treatment" visit. If pregnancy occurs within the follow-up period, it needs to be followed through 8 weeks after the end of pregnancy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

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 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

...and 6 more locations

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

To assess the pharmacodynamic effects of SCV 07 and the pharmacokinetics as a monotherapy and in combination with ribavirin

Time frame: 8 weeks