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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968357
• Other study ID #: SCI-SCV-HCV-P2-001
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2009
• Last updated: June 6, 2012
• Start date: September 2009
• Est. completion date: January 2011

Study information

• Verified date: June 2012
• Source: SciClone Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Other known NCT identifiers

• NCT00514631

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	AGMG Clinical Research	Anaheim	California
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Paul Thuluvath	Baltimore	Maryland
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Duke University Department of Medicine	Durham	North Carolina
United States	Kaiser Permanente	Falls Church	Virginia
United States	Baylor College of Medicine (VAMC 15)	Houston	Texas
United States	Arapahoe Gastroenterology	Littleton	Colorado
United States	Impact Clinical Trials	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Commonwealth Biomedical Research, LLC	Madisonville	Kentucky
United States	University of Miami School of Medicine	Miami	Florida
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	A Professional Corporation	Palm Springs	California
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Washington Hospital Center-MedStar Research Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
SciClone Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess the pharmacodynamic effects of SCV 07 and the pharmacokinetics as a monotherapy and in combination with ribavirin		8 weeks	No

External Links

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