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
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
1 other identifier
interventional
40
1 country
16
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2009
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2009
CompletedFirst Posted
Study publicly available on registry
August 31, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJune 8, 2012
June 1, 2012
1.3 years
August 27, 2009
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
8 weeks
Secondary Outcomes (1)
To assess the pharmacodynamic effects of SCV 07 and the pharmacokinetics as a monotherapy and in combination with ribavirin
8 weeks
Study Arms (1)
SCV-07
EXPERIMENTALCohort 1: SCV-07 0.1 mg/kg. Cohort 2: 1.0 mg/kg per day administered SC
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 Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
AGMG Clinical Research
Anaheim, California, 92803, United States
Impact Clinical Trials
Los Angeles, California, 90036, United States
A Professional Corporation
Palm Springs, California, 92262, United States
Arapahoe Gastroenterology
Littleton, Colorado, 80120, United States
Washington Hospital Center-MedStar Research Institute
Washington D.C., District of Columbia, 20010, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30308, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431, United States
Paul Thuluvath
Baltimore, Maryland, 21202, United States
Duke University Department of Medicine
Durham, North Carolina, 27710, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37212, United States
Baylor College of Medicine (VAMC 15)
Houston, Texas, United States
Kaiser Permanente
Falls Church, Virginia, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2009
First Posted
August 31, 2009
Study Start
September 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
June 8, 2012
Record last verified: 2012-06