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

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ClinicalTrials.gov Identifier: NCT00456248
Recruitment Status : Terminated (slow enrollment)
First Posted : April 4, 2007
Last Update Posted : October 15, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Infergen and ribavirin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2007
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  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. [ Time Frame: 1.5 years ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456248

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
Principal Investigator: Mitchell L Schiffman, MD Virginia Commonwealth University
More Information

Responsible Party: Kadmon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00456248     History of Changes
Other Study ID Numbers: VRX-CIFN-402
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: October 2012

Keywords provided by Kadmon Pharmaceuticals:
Chronic Hepatitis C

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon alfacon-1
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs