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

Kadmon

Status and phase: Terminated; Phase 4

Conditions: Hepatitis C

Treatments: Drug: Infergen and ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00456248

VRX-CIFN-402

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 3 patient groups

1

Experimental group

Description:

Infergen 15 ug QD plus RBV for 36 weeks

Treatment:

Drug: Infergen and ribavirin

2

Experimental group

Description:

Infergen 15 ug QD plus RBV for 48 weeks

Treatment:

Drug: Infergen and ribavirin

3

Active Comparator group

Treatment:

Drug: Infergen and ribavirin