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

This study has been completed.
Getz Pharma
Information provided by:
Aga Khan University Identifier:
First received: July 16, 2007
Last updated: January 9, 2008
Last verified: January 2008
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 Intervention Phase
Hepatitis C Chronic Disease Treatment Drug: 16 weeks Interferon Tiw with Ribavirin Drug: 24 weeks Interferon Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Sustained Virological response [ Time Frame: six months after stopping treatment ]

Secondary Outcome Measures:
  • Safety of short course of Interferon & Ribavirin [ Time Frame: Four or Six months ]

Enrollment: 150
Study Start Date: May 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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

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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Please refer to this study by its identifier: NCT00502970

The Aga Khan University, Stadium Road
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Getz Pharma
Principal Investigator: Saeed S Hamid, FRCP The Aga Khan University
  More Information

Responsible Party: Proffessor Saeed Hamid, The Aga Khan University Identifier: NCT00502970     History of Changes
Other Study ID Numbers: 302-Med/ERC-04
Study First Received: July 16, 2007
Last Updated: January 9, 2008

Keywords provided by Aga Khan University:
Chronic HCV

Additional relevant MeSH terms:
Hepatitis C
Chronic Disease
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Disease Attributes
Pathologic Processes
Iron-Dextran Complex
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Hematinics processed this record on September 21, 2017