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

NCT00456248 | Terminated Phase 4 DMC

• 1 other identifier: VRX-CIFN-402
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

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.

Conditions

Hepatitis C

Keywords

Chronic Hepatitis C; Liver; Pegylated; Interferon; Ribavirin; Combination; Nonresponder; Relapser; HCV; Infergen; SVR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks

  1.5 years

Study Arms (3)

1

EXPERIMENTAL

Infergen 15 ug QD plus RBV for 36 weeks

Drug: Infergen and ribavirin

2

EXPERIMENTAL

Infergen 15 ug QD plus RBV for 48 weeks

Drug: Infergen and ribavirin

3

ACTIVE COMPARATOR

Drug: Infergen and ribavirin

Interventions

Infergen and ribavirin DRUG

Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kadmon Corporation, LLC: lead

Study Sites (4)

Atlantic Gastroenterology Associates

Atlanta, Georgia, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, United States

Location

Caroline Digestive Health Associates

Harrisburg, North Carolina, United States

Location

Liver Institute at Methodist Dallas

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

interferon alfacon-1; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mitchell L Schiffman, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2007
• First Posted: April 4, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: October 15, 2012

Record last verified: 2012-10

Locations

US (4)