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

Phase 2

Completed

• Conditions: Genotype 3; Non-responders; Hepatitis C; Relapsers
• Interventions: Drug: interferon alpha-2b, ribavirin, interferon-gamma,; Drug: interferon alpha-2b, ribavirin, amantadine

• Registration Number: NCT00538811
• Lead Sponsor: Aga Khan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-02
• Study First Posted: 2007-10-03
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-26
• Last Update Posted: 2010-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	interferon alpha-2b, ribavirin, interferon-gamma,	Interferon alpha, ribavirin, interferon gamma
2	interferon alpha-2b, ribavirin, amantadine	Interferon alpha, ribavirin, amantadine

Trial Locations

Locations (2)

The Aga Khan University Hospital; 🇵🇰 Karachi, Pakistan

Medicare Clinic; 🇵🇰 Karachi, Pakistan