Short Course of Interferon Treatment in Patients With HCV Infection (STAR)
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ClinicalTrials.gov Identifier: NCT00502970 |
Recruitment Status :
Completed
First Posted : July 18, 2007
Last Update Posted : January 11, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C Chronic Disease Treatment | Drug: 16 weeks Interferon Tiw with Ribavirin Drug: 24 weeks Interferon | Phase 4 |

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 |

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 |
- Sustained Virological response [ Time Frame: six months after stopping treatment ]
- Safety of short course of Interferon & Ribavirin [ Time Frame: Four or Six months ]

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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.

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
Pakistan | |
The Aga Khan University, Stadium Road | |
Karachi, Sindh, Pakistan, 74800 |
Principal Investigator: | Saeed S Hamid, FRCP | The Aga Khan University |
Responsible Party: | Proffessor Saeed Hamid, The Aga Khan University |
ClinicalTrials.gov Identifier: | NCT00502970 |
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 |
Chronic HCV Treatment |
Hepatitis C Hepatitis Chronic Disease Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections |
Disease Attributes Pathologic Processes Interferons Ribavirin Iron-Dextran Complex Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Hematinics |