Clinical trial NCT00456248: Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin
Official title: Phase 4 Study Using Infergen and Ribavirin in Patients With Chronic Hepatitis C Virus Who Achieved Partial Response to Peginterferon-alfa and Ribavirin Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C
Liver
Pegylated
Interferon
Ribavirin
Combination
Nonresponder
Relapser
HCV
Infergen
SVR
Lead sponsor: Kadmon Corporation, LLC
Sponsor class: INDUSTRY
First posted: 2007-04-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1.5 years
Secondary outcomes:
measure: Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlantic Gastroenterology Associates
state: Georgia
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Harrisburg
country: United States
facility: Caroline Digestive Health Associates
state: North Carolina
city: Dallas
country: United States
facility: Liver Institute at Methodist Dallas
state: Texas
Study officials:
affiliation: Virginia Commonwealth University
name: Mitchell L Schiffman, MD
role: PRINCIPAL_INVESTIGATOR
References: