Clinical trial NCT00538811: Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Non-responders
Official title: Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Patients Who Are Non-responders to Interferon Alpha Plus Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hepatitis C
Genotype 3
Non-responders
Relapsers
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2007-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Medicare Clinic
city: Karachi
country: Pakistan
facility: The Aga Khan University Hospital
Study officials:
affiliation: The Aga Khan University Hospital
name: Zaigham Abbas, FCPS, FACG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abbas Z, Raza S, Hamid S, Jafri W. Randomized controlled trial of interferon gamma versus amantadine in combination with interferon alpha and ribavirin for hepatitis C genotype 3 non-responders and relapsers. J Pak Med Assoc. 2012 Apr;62(4):338-43.