Interferon-Gamma With Interferon Alpha and Ribavirin for Hepatitis C Non-Responders
Information source: Aga Khan University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C; Genotype 3; Non-Responders; Relapsers
Intervention: interferon alpha-2b, ribavirin, interferon-gamma, (Drug); interferon alpha-2b, ribavirin, amantadine (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Aga Khan University Official(s) and/or principal investigator(s):
Zaigham Abbas, FCPS, FACG, Principal Investigator, Affiliation: The Aga Khan University Hospital
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.
Clinical Details
Official title: Interferon-Gamma With Interferon Alpha and Ribavirin for Hepatitis C Patients Who Are Non-Responders to Interferon Alpha Plus Ribavirin
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
The Aga Khan University Hospital, Karachi 74800, Pakistan; Recruiting
Zaigham Abbas, FCPS, FACG, Phone: +92-21-4930051, Email: zaigham@akunet.org
Javed Yakoob, PhD, Phone: +92-21-4930051, Email: yakoobjaved@hotmail.com
Zaigham Abbas, FACG, Principal Investigator
Saeed Hamid, FRCP, Sub-Investigator
Wasim Jafri, FRCP, Sub-Investigator
Medicare Clinic, Karachi 74800, Pakistan; Recruiting
Zaigham Abbas, FCPS, Phone: +92-21-4934294, Email: zaigham@akunet.org
Zaigham Abbas, FACG, Principal Investigator
Additional Information
Last updated: October 2, 2007
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