Short Course of Interferon Treatment in Patients With HCV Infection (STAR)
This study has been completed.
Sponsor:
Aga Khan University
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
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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 (Adult) |
| 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
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
| 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 C Hepatitis Chronic Disease Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Liver Diseases Digestive System Diseases |
Disease Attributes Pathologic Processes Interferons Ribavirin Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 26, 2016