A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy

Study Overview
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Brief Summary
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The purpose of this research study is to find out the effect of the investigational drug NOV-205 on the level of hepatitis C virus in the blood and whether NOV-205 is well-tolerated at different doses when taken by subjects with hepatitis C.

Official Title
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A Phase 2 Trial of NOV-205 in Chronic Viral Hepatitis C Patients (Genotype 1) Who Have Failed Treatment With Pegylated Interferon Plus Ribavirin

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: NOV-205


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A serum HCV RNA level of >100,000 IU/ml using a quantitative, branched-chain-DNA (bDNA)-based assay (lower limit of quantitation =  650 IU/ml) or other equally sensitive quantitative methods. Infection with genotype 1 HCV Documented failure to respond to treatment (defined as a patient who did not achieve an early viral response (EVR) (≥2 log reduction in serum HCV RNA or undetectable HCV RNA after 12 weeks of treatment) OR is serum HCV RNA positive after 24 weeks of treatment with pegylated interferon plus ribavirin for hepatitis C Adequate laboratory parameters Women of childbearing potential willing to use two acceptable methods of birth control during trial participation or are sterile or post-menopausal (defined as not having a menstrual cycle for greater than two years) Sexually active male subjects are practicing acceptable methods of contraception during trial participation Have the ability to understand the requirements of the trial, have provided written informed consent, and agree to abide by the trial restrictions and to return for the required assessments The subject must be able to self administer daily subcutaneous injections or their caregiver must be able to administer daily subcutaneous injections Exclusion Criteria: Clinical, laboratory, or histological evidence of liver cirrhosis Evidence of hepatic decompensation (presence of or a history of ascites, hepatic encephalopathy, variceal bleeding, or hepatocellular carcinoma) Co-infection with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) (as determined by presence of hepatitis B surface antigen (HBsAg) Have received pegylated interferon and/or ribavirin within the 60 days prior to enrollment Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol Pregnant female or nursing mother

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single<br>single-arm study | Drug: NOV-205<br>* There will be 4 treatment Groups with 10 patients in each group: Group A: 30 mg NOV-205 daily subcutaneous administration for 49 days Group B: 30 mg NOV-205 daily subcutaneous administration for 98 days Group C: 60 mg NOV-205 daily subcutaneous administration for 49 days Group D: 60 mg NOV-205 daily subcutaneous administration for 98 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate changes in viral load |  | 16 months | 
| To evaluate changes in serum ALT and AST levels |  | 16 months | 
| To evaluate the durability of any changes in viral load and serum ALT and AST |  | 16 months | 
| To establish the safety profile of NOV-205 |  | 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C, chronic HCV, viral HCV, genotype 1, failed treatment with pegylated interferon plus ribavirin