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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538811
• Other study ID #: 648-Med
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 2, 2007
• Last updated: October 26, 2010

Study information

• Verified date: October 2010
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Genotype 3
• Hepatitis
• Hepatitis A
• Hepatitis C
• Non-responders
• Relapsers

Intervention

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

• interferon alpha-2b, ribavirin, amantadine

Locations

Country	Name	City	State
Pakistan	Medicare Clinic	Karachi
Pakistan	The Aga Khan University Hospital	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan,