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

Hepatitis C Clinical Trial

— ENHANCE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00456248
• Other study ID #: VRX-CIFN-402
• Status: Terminated
• Phase: Phase 4
• First received: April 2, 2007
• Last updated: October 11, 2012
• Start date: February 2007
• Est. completion date: October 2007

Study information

• Verified date: October 2012
• Source: Kadmon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• Infergen and ribavirin
Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks

Locations

Country	Name	City	State
United States	Atlantic Gastroenterology Associates	Atlanta	Georgia
United States	Liver Institute at Methodist Dallas	Dallas	Texas
United States	Caroline Digestive Health Associates	Harrisburg	North Carolina
United States	Tulane University School of Medicine	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Kadmon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks		1.5 years	No