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Interferon-Gamma With Interferon Alpha and Ribavirin for Hepatitis C Non-Responders
This study is currently recruiting participants.
Verified by Aga Khan University, September 2007
Sponsored by: Aga Khan University
Information provided by: Aga Khan University
ClinicalTrials.gov Identifier: NCT00538811
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Genotype 3
Non-Responders
Relapsers
Drug: interferon alpha-2b, ribavirin, interferon-gamma,
Drug: interferon alpha-2b, ribavirin, amantadine
Phase II
Phase III

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Ribavirin Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Amantadine Amantadine hydrochloride Amantadine sulfate Interferon gamma-1b
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Interferon-Gamma With Interferon Alpha and Ribavirin for Hepatitis C Patients Who Are Non-Responders to Interferon Alpha Plus Ribavirin

Further study details as provided by Aga Khan University:

Estimated Enrollment: 40
Arms Assigned Interventions
1: Experimental
Interferon alpha, ribavirin, interferon gamma
Drug: interferon alpha-2b, ribavirin, interferon-gamma,
2: Active Comparator
Interferon alpha, ribavirin, amantadine
Drug: interferon alpha-2b, ribavirin, amantadine

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538811

Locations
Pakistan
The Aga Khan University Hospital Recruiting
Karachi, Pakistan, 74800
Contact: Zaigham Abbas, FCPS, FACG     +92-21-4930051     zaigham@akunet.org    
Contact: Javed Yakoob, PhD     +92-21-4930051     yakoobjaved@hotmail.com    
Principal Investigator: Zaigham Abbas, FACG            
Sub-Investigator: Saeed Hamid, FRCP            
Sub-Investigator: Wasim Jafri, FRCP            
Medicare Clinic Recruiting
Karachi, Pakistan, 74800
Contact: Zaigham Abbas, FCPS     +92-21-4934294     zaigham@akunet.org    
Principal Investigator: Zaigham Abbas, FACG            
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: Zaigham Abbas, FCPS, FACG The Aga Khan University Hospital
  More Information

Study ID Numbers: 648-Med
Study First Received: October 2, 2007
Last Updated: October 2, 2007
ClinicalTrials.gov Identifier: NCT00538811  
Health Authority: Pakistan: Research Ethics Committee

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Liver Diseases
Interferon Type II
Ribavirin
Interferons
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis C
Interferon Alfa-2a
Amantadine
Interferon Alfa-2b
Interferon-gamma, Recombinant

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009