Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Non-responders

Study Overview
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Brief Summary
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When administered simultaneously, interferon-alpha 2b + interferon-gamma result in dramatic antiviral synergy.Ribavirin has shown to enhance interferon-gamma levels in patients with chronic hepatitis C treated with interferon-alpha. Enhancement of immune responses, especially those related to type-1 T helper cell activity, may contribute to better efficacy in combining ribavirin with IFN-alpha for treatment of chronic hepatitis C. The aim of the present study is to evaluate the efficacy and safety of a triple regimen, a combination treatment with Interferon gamma, Interferon alfa-2b plus Ribavirin in patients who have not previously responded to interferon alpha in combination of ribavirin.

Official Title
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Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Patients Who Are Non-responders to Interferon Alpha Plus Ribavirin

Conditions
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Hepatitis C, Genotype 3, Non-responders, Relapsers

Intervention / Treatment
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* Drug: interferon alpha-2b, ribavirin, interferon-gamma,
* Drug: interferon alpha-2b, ribavirin, amantadine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-responders and relapsers to previous interferon and ribavirin therapy given for six months HCV genotype 3 Compensated liver disease Hb ≥10 g/dl (females),≥11 g/dl (males) Platelets count ≥ 100,000 / cubic mm Neutrophils count ≥1,500/cubic mm ≥18 years to ≤ 70 years. At least one abnormal ALT value in the last year. TSH level within normal limits. Non pregnant adult females. Absence of drug or alcohol abuse. Informed consent given by the patient Exclusion Criteria: Patient younger than 18 yrs and older than 70 yrs. Hepatitis B or HIV co-infection. Severe renal dysfunction or creatinine clearance less than 50 ml/min Pregnant women or breast feeding women. Suspected hypersensitivity to Interferon alpha, gamma or ribavirin. Decompensated liver cirrhosis. History or any other evidence of other causes of CLD other than hepatitis C infection ( like hemochromatosis,, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure, Wilson's disease,Drug induced liver disease) Active malignant disease. Any known pre-existing medical condition that could interfere with subject's participation or completion of study such as psychiatric condition, seizures disorder requiring medications, co existing heart diseases, lung diseases, poorly controlled diabetes, auto immune diseases, gout) History of interferon and/or ribavirin intolerance

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Interferon alpha, ribavirin, interferon gamma | Drug: interferon alpha-2b, ribavirin, interferon-gamma,<br> <br> |
| Active Comparator: 2<br>Interferon alpha, ribavirin, amantadine | Drug: interferon alpha-2b, ribavirin, amantadine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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