Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Non-responders
Primary Purpose
Hepatitis C, Genotype 3, Non-responders
Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
interferon alpha-2b, ribavirin, interferon-gamma,
interferon alpha-2b, ribavirin, amantadine
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
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
Sites / Locations
- Medicare Clinic
- The Aga Khan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Interferon alpha, ribavirin, interferon gamma
Interferon alpha, ribavirin, amantadine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00538811
Brief Title
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
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Aga Khan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Genotype 3, Non-responders, Relapsers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Interferon alpha, ribavirin, interferon gamma
Arm Title
2
Arm Type
Active Comparator
Arm Description
Interferon alpha, ribavirin, amantadine
Intervention Type
Drug
Intervention Name(s)
interferon alpha-2b, ribavirin, interferon-gamma,
Intervention Type
Drug
Intervention Name(s)
interferon alpha-2b, ribavirin, amantadine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaigham Abbas, FCPS, FACG
Organizational Affiliation
The Aga Khan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicare Clinic
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan
Facility Name
The Aga Khan University Hospital
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22755276
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.
Results Reference
derived
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Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Non-responders
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