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

NCT ID: NCT00538811

Last Updated: 2010-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C Genotype 3 Non-responders Relapsers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Interferon alpha, ribavirin, interferon gamma

Group Type EXPERIMENTAL

interferon alpha-2b, ribavirin, interferon-gamma,

Intervention Type DRUG

2

Interferon alpha, ribavirin, amantadine

Group Type ACTIVE_COMPARATOR

interferon alpha-2b, ribavirin, amantadine

Intervention Type DRUG

Interventions

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interferon alpha-2b, ribavirin, interferon-gamma,

Intervention Type DRUG

interferon alpha-2b, ribavirin, amantadine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Principal Investigators

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Zaigham Abbas, FCPS, FACG

Role: PRINCIPAL_INVESTIGATOR

The Aga Khan University Hospital

Locations

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Medicare Clinic

Karachi, , Pakistan

Site Status

The Aga Khan University Hospital

Karachi, , Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type DERIVED
PMID: 22755276 (View on PubMed)

Other Identifiers

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648-Med

Identifier Type: -

Identifier Source: org_study_id