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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00538811
First Posted: October 3, 2007
Last Update Posted: October 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aga Khan University
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Patients Who Are Non-responders to Interferon Alpha Plus Ribavirin

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538811


Locations
Pakistan
Medicare Clinic
Karachi, Pakistan, 74800
The Aga Khan University Hospital
Karachi, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: Zaigham Abbas, FCPS, FACG The Aga Khan University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00538811     History of Changes
Other Study ID Numbers: 648-Med
First Submitted: October 2, 2007
First Posted: October 3, 2007
Last Update Posted: October 27, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Interferon-gamma
Amantadine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents