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

This study has been completed.
Sponsor:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00538811
First received: October 2, 2007
Last updated: October 26, 2010
Last verified: October 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538811

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

No publications provided by Aga Khan University

Additional 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
Study First Received: October 2, 2007
Last Updated: October 26, 2010
Health Authority: Pakistan: Research Ethics Committee

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
Amantadine
Interferon-gamma
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on October 02, 2014