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

This study has been completed.
Sponsor:
Collaborator:
Getz Pharma
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00502970
First received: July 16, 2007
Last updated: January 9, 2008
Last verified: January 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of short course of Interferon & Ribavirin [ Time Frame: Four or Six months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

Keywords provided by Aga Khan University:
Chronic HCV
Treatment

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Chronic Disease
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Disease Attributes
Pathologic Processes
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014