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

August 27, 2009
June 6, 2012
September 2009
January 2011   (final data collection date for primary outcome 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To assess the safety of SCV-07 at 2 concentrations 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 ]
  • To assess safety of SCV-07 at 2 concentrations and to assess immunomodulatory effects of SCV-07 given at 2 dose levels in combination with ribavirin. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00968357 on ClinicalTrials.gov Archive Site
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 ]
  • Pharmacodynamics and Pharmacokinetics of SCV-07 [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Chronic Hepatitis C
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.
Experimental: SCV-07
Cohort 1: SCV-07 0.1 mg/kg. Cohort 2: 1.0 mg/kg per day administered SC
Intervention: Drug: SCV-07
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00968357
SCI-SCV-HCV-P2-001
Yes
SciClone Pharmaceuticals
SciClone Pharmaceuticals
Not Provided
Not Provided
SciClone Pharmaceuticals
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP