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

S

SciClone Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Chronic Hepatitis C

Treatments

Drug: SCV-07

Study type

Interventional

Funder types

Industry

Identifiers

NCT00968357
SCI-SCV-HCV-P2-001

Details and patient eligibility

About

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).

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

SCV-07
Experimental group
Description:
Cohort 1: SCV-07 0.1 mg/kg. Cohort 2: 1.0 mg/kg per day administered SC
Treatment:
Drug: SCV-07

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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