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

This study has been terminated.
(slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Kadmon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00456248
First received: April 2, 2007
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Infergen and ribavirin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Kadmon Pharmaceuticals:

Primary Outcome Measures:
  • 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. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: February 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Infergen 15 ug QD plus RBV for 36 weeks
Drug: Infergen and ribavirin
Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks
Experimental: 2
Infergen 15 ug QD plus RBV for 48 weeks
Drug: Infergen and ribavirin
Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks
Active Comparator: 3 Drug: Infergen and ribavirin
Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456248

Locations
United States, Georgia
Atlantic Gastroenterology Associates
Atlanta, Georgia, United States
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States
United States, North Carolina
Caroline Digestive Health Associates
Harrisburg, North Carolina, United States
United States, Texas
Liver Institute at Methodist Dallas
Dallas, Texas, United States
Sponsors and Collaborators
Kadmon Pharmaceuticals
Investigators
Principal Investigator: Mitchell L Schiffman, MD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Kadmon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00456248     History of Changes
Other Study ID Numbers: VRX-CIFN-402
Study First Received: April 2, 2007
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Kadmon Pharmaceuticals:
Chronic Hepatitis C
Liver
Pegylated
Interferon
Ribavirin
Combination
Nonresponder
Relapser
HCV
Infergen
SVR

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Interferon alfacon-1
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014