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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00502970
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : January 11, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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

  Show Detailed Description

Study Design

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
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502970


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

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    Key Record Dates
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