Clinical trial NCT00968357: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: SCV-07
relapsers
Hepatitis C
Lead sponsor: SciClone Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 8 weeks
Secondary outcomes:
measure: To assess the pharmacodynamic effects of SCV 07 and the pharmacokinetics as a monotherapy and in combination with ribavirin
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: AGMG Clinical Research
state: California
city: Los Angeles
country: United States
facility: Impact Clinical Trials
state: California
city: Palm Springs
country: United States
facility: A Professional Corporation
state: California
city: Littleton
country: United States
facility: Arapahoe Gastroenterology
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center-MedStar Research Institute
state: District of Columbia
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, LLC
state: Kentucky
city: Baltimore
country: United States
facility: Paul Thuluvath
state: Maryland
city: Durham
country: United States
facility: Duke University Department of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine (VAMC 15)
state: Texas
city: Falls Church
country: United States
facility: Kaiser Permanente
state: Virginia
Study officials:
References: