Short Course of Interferon Treatment in Patients With HCV Infection

NCT00502970 | Completed Phase 4 DMC

• 1 other identifier: 302-Med/ERC-04
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; Chronic Disease; Treatment

Keywords

Chronic HCV; Treatment

Outcome Measures

Primary Outcomes (1)

• Sustained Virological response

  six months after stopping treatment

Secondary Outcomes (1)

• Safety of short course of Interferon & Ribavirin

  Four or Six months

Study Arms (2)

1

EXPERIMENTAL

16 weeks Interferon Tiw with Ribavirin

Drug: 16 weeks Interferon Tiw with Ribavirin

2

ACTIVE COMPARATOR

24 weeks Interferon Tiw with Ribavirin

Drug: 24 weeks Interferon

Interventions

16 weeks Interferon Tiw with Ribavirin DRUG

16 weeks Interferon Tiw

Also known as: Uniferon

1

24 weeks Interferon DRUG

24 weeks Interferon Tiw with Ribavirin

Also known as: Uniferon

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead
• Getz Pharma: collaborator

Study Sites (1)

The Aga Khan University, Stadium Road

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Hepatitis C; Chronic Disease

Interventions

Ribavirin; Iron-Dextran Complex; Interferons

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Saeed S Hamid, FRCP

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 18, 2007
• Study Start: May 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: January 11, 2008

Record last verified: 2008-01

Locations

PA (1)