Short Course of Interferon Treatment in Patients With HCV Infection (STAR)

Study Description

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Brief Summary:

To determine if a shorter course of interferon and ribavirin therapy will be sufficient in carefully selected patients with chronic hepatitis C virus genotype 3 infection, as compared to the standard length of treatment of 6 months.

Condition or disease	Intervention/treatment	Phase
Hepatitis C; Chronic Disease; Treatment	Drug: 16 weeks Interferon Tiw with Ribavirin; Drug: 24 weeks Interferon	Phase 4

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Trial Comparing a Short Course Versus Standard Treatment in Patients With Chronic Hepatitis C Virus Infection
Study Start Date :	May 2004
Actual Primary Completion Date :	November 2007
Actual Study Completion Date :	November 2007

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; 16 weeks Interferon Tiw with Ribavirin	Drug: 16 weeks Interferon Tiw with Ribavirin; 16 weeks Interferon Tiw; Other Name: Uniferon
Active Comparator: 2; 24 weeks Interferon Tiw with Ribavirin	Drug: 24 weeks Interferon; 24 weeks Interferon Tiw with Ribavirin; Other Name: Uniferon

Outcome Measures

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Primary Outcome Measures :

1. Sustained Virological response [ Time Frame: six months after stopping treatment ]

Secondary Outcome Measures :

1. Safety of short course of Interferon & Ribavirin [ Time Frame: Four or Six months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Adult males and non-pregnant females (more than 18 and less than equal to 50 years of age).
• Treatment naïve patients.
• Serological evidence of hepatitis C infection by an anti-HCV antibody test
• HCV PCR positive
• Genotype 3
• Absence of cirrhosis on liver biopsy.
• Absence of alcohol or drug abuse.

Exclusion Criteria:

• Patients who do not consent to be included in the study.
• Pregnant or breast feeding females.
• Patients with a hemoglobin of <10g/dl, ANC <1500c/mm, and a platelet count <90000c/mm.
• Genotype non 3
• HCV PCR positive at the end of 4 weeks of treatment.
• Presence of cirrhosis on liver biopsy.
• Decompensated liver disease.
• History or other evidence of a medical condition associated with chronic liver disease other than CHC (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
• History of having received IFN, PEG-IFN, RBV therapy previously.
• History of systemic antiviral therapy or investigational drug 3 months prior to the first dose of study treatment.
• Patients expected to need systemic antiviral therapy at any time during their participation in the study.
• Exceptions from the last two exclusion criteria are patients who have had a limited (less than 7 day) course of acyclovir or valacyclovir for herpetic lesions more than 1 month prior to the first administration of trial treatment.

Contacts and Locations

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Locations

Pakistan
The Aga Khan University, Stadium Road
Karachi, Sindh, Pakistan, 74800

Sponsors and Collaborators

Aga Khan University

Getz Pharma

Investigators

Principal Investigator:	Saeed S Hamid, FRCP	The Aga Khan University

More Information

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Responsible Party:	Proffessor Saeed Hamid, The Aga Khan University
ClinicalTrials.gov Identifier:	NCT00502970 History of Changes
Other Study ID Numbers:	302-Med/ERC-04
First Posted:	July 18, 2007
Last Update Posted:	January 11, 2008
Last Verified:	January 2008

Keywords provided by Aga Khan University:

Chronic HCV; Treatment

Additional relevant MeSH terms:

Hepatitis; Hepatitis C; Chronic Disease; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Disease Attributes	Pathologic Processes; Interferons; Ribavirin; Iron-Dextran Complex; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Hematinics