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

Aga Khan University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Genotype 3

Hepatitis C

Non-responders

Relapsers

Treatments

Drug: interferon alpha-2b, ribavirin, amantadine

Drug: interferon alpha-2b, ribavirin, interferon-gamma,

Study type

Interventional

Funder types

Other

Identifiers

NCT00538811

648-Med

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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