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
NCT ID: NCT00968357
Last Updated: 2012-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2009-09-30
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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SCV-07
Cohort 1: SCV-07 0.1 mg/kg. Cohort 2: 1.0 mg/kg per day administered SC
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* Clinical evidence of cirrhosis
* Autoimmune hepatitis or other autoimmune/immune-active diseases
* Insulin-dependent diabetes
18 Years
ALL
No
Sponsors
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SciClone Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Paul Thuluvath
Baltimore, Maryland, United States
Duke University Department of Medicine
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine (VAMC 15)
Houston, Texas, United States
Kaiser Permanente
Falls Church, Virginia, United States
Countries
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Related Links
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Pharmaceutical Company
Other Identifiers
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SCI-SCV-HCV-P2-001
Identifier Type: -
Identifier Source: org_study_id
NCT00514631
Identifier Type: -
Identifier Source: nct_alias
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