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

Phase 4

Terminated

• Conditions: Hepatitis C
• Interventions: Drug: Infergen and ribavirin

• Registration Number: NCT00456248
• Lead Sponsor: Kadmon Corporation, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-04-02
• Study First Submitted QC: 2007-04-02
• Study First Posted: 2007-04-04
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-11
• Last Update Posted: 2012-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Infergen and ribavirin	Infergen 15 ug QD plus RBV for 36 weeks
2	Infergen and ribavirin	Infergen 15 ug QD plus RBV for 48 weeks
3	Infergen and ribavirin	-

Primary Outcome Measures

Name	Time	Method
To evaluate the proportion of patients with a sustained viral response (SVR) defined as undetectable serum HCV RNA at the end of the 24 week post-treatment follow-up period.	1.5 years

Secondary Outcome Measures

Name	Time	Method
Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks	1.5 years

Trial Locations

Locations (4)

Atlantic Gastroenterology Associates; 🇺🇸 Atlanta, Georgia, United States

Caroline Digestive Health Associates; 🇺🇸 Harrisburg, North Carolina, United States

Liver Institute at Methodist Dallas; 🇺🇸 Dallas, Texas, United States

Tulane University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States