Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00968357
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : June 8, 2012
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: SCV-07 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Phase 2, Multicenter, Multidose, Open-Label Study to Evaluate the Safety and Immunomodulatory Effects of SCV-07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Genotype 1 Chronic Hepatitis C Who Have Relapsed After a Response to a Course of at Least 44 Weeks Treatment With Pegylated Interferon and Ribavirin
Study Start Date : September 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: SCV-07
Cohort 1: SCV-07 0.1 mg/kg. Cohort 2: 1.0 mg/kg per day administered SC
Drug: SCV-07
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. To assess the pharmacodynamic effects of SCV 07 and the pharmacokinetics as a monotherapy and in combination with ribavirin [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00968357

Layout table for location information
United States, California
AGMG Clinical Research
Anaheim, California, United States, 92803
Impact Clinical Trials
Los Angeles, California, United States, 90036
A Professional Corporation
Palm Springs, California, United States, 92262
United States, Colorado
Arapahoe Gastroenterology
Littleton, Colorado, United States, 80120
United States, District of Columbia
Washington Hospital Center-MedStar Research Institute
Washington, District of Columbia, United States, 20010
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
United States, Florida
University of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30308
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States, 42431
United States, Maryland
Paul Thuluvath
Baltimore, Maryland, United States, 21202
United States, North Carolina
Duke University Department of Medicine
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37212
United States, Texas
Baylor College of Medicine (VAMC 15)
Houston, Texas, United States
United States, Virginia
Kaiser Permanente
Falls Church, Virginia, United States
Sponsors and Collaborators
SciClone Pharmaceuticals

Additional Information:
Layout table for additonal information
Responsible Party: SciClone Pharmaceuticals Identifier: NCT00968357     History of Changes
Obsolete Identifiers: NCT00514631
Other Study ID Numbers: SCI-SCV-HCV-P2-001
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: June 2012
Keywords provided by SciClone Pharmaceuticals:
Hepatitis C
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents