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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: SCV-07


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCV-07<br>Cohort 1: SCV-07 0.1 mg/kg. Cohort 2: 1.0 mg/kg per day administered SC | Drug: SCV-07<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacodynamic effects of SCV 07 and the pharmacokinetics as a monotherapy and in combination with ribavirin |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCV-07, relapsers, Hepatitis C