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Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin | Clinical Trials | Clareo Health

TERMINATEDPHASE4

Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin

Phase 4 Study Using Infergen and Ribavirin in Patients With Chronic Hepatitis C Virus Who Achieved Partial Response to Peginterferon-alfa and Ribavirin Therapy

NCT00456248•Kadmon Corporation, LLC

View on ClinicalTrials.gov

Summary

This is a 60-to-72 week multicenter study to evaluate Infergen and Ribavirin in patients with Chronic Hepatitis C Virus after partial response to treatment using peginterferon-alfa and Ribavirin therapy. The study will be conducted at approximately 50 sites across the United States.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, at least 18 years of age and no older than 65 years with compensated chronic HCV infection based on a history of positive serum anti-HCV antibody and/or HCV RNA
•Diagnosed with HCV Genotype 1, 4, 5 or 6 as determined during the screening visit
•The starting doses in the initial treatment must have been 1.5 μg/kg/week PEG-Intron or 180 μg/week Pegasys, and 1000/1200 mg/day ribavirin based on body weight. Patients must have been at least 80% compliant during the initial peginterferon/ribavirin therapy, per patient account.
•Liver biopsy indicating F0-F4 must be performed within 3 years prior to screening. Documentation of the results of the biopsy must be available. If documentation is not available, a liver biopsy must be performed during the screening period. (A maximum of 10 patients in each of the three treatment groups will be patients with a fibrosis score of F4)
•Documented partial response after 12 weeks of treatment as a therapy-naive patient with one course of peginterferon alfa-2a (PEGASYS) and Ribavirin or peginterferon alfa-2b (Peg-INTRON) and Ribavirin

Exclusion Criteria

•Detectable HCV RNA after 12 weeks if initial peginterferon alfa/ribavirin therapy and \<2 log decrease in HCV RNA at Week 12 from baseline.
•HCV Genotype 2 or 3
•Severe neuropsychiatric disorder.
•History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease.
•Known HIV infection or positive HIV at screening.
•Pregnant or breast-feeding patients.
•Underlying autoimmune disease

Locations (4)

Atlantic Gastroenterology Associates

Atlanta, Georgia, United States

Tulane University School of Medicine

New Orleans, Louisiana, United States

Caroline Digestive Health Associates

Harrisburg, North Carolina, United States

Liver Institute at Methodist Dallas

Dallas, Texas, United States

Key Dates

Start Date

February 1, 2007

Primary Completion Date

October 1, 2007

Completion Date

October 1, 2007

Last Updated

October 15, 2012

Enrollment

ACTUAL participants

Conditions

Hepatitis C

Interventions

Infergen and ribavirin

DRUG

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RECRUITINGNA

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HIV/AIDSHepatitis C+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin

Inclusion Criteria

Exclusion Criteria

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