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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SciClone Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00968357
First received: August 27, 2009
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Chronic Hepatitis C
Drug: SCV-07
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SciClone Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the pharmacodynamic effects of SCV 07 and the pharmacokinetics as a monotherapy and in combination with ribavirin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968357

Locations
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
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Washington Hospital Center-MedStar Research Institute
Washington, District of Columbia, United States, 20010
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
  More Information

Additional Information:
No publications provided

Responsible Party: SciClone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00968357     History of Changes
Obsolete Identifiers: NCT00514631
Other Study ID Numbers: SCI-SCV-HCV-P2-001
Study First Received: August 27, 2009
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by SciClone Pharmaceuticals:
SCV-07
relapsers
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014