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Study of High Dosage CIFN Plus RBV for HCV Genotype 1 Infected Patients Who Are Nonresponders to Prior Therapy

This study has been completed.
Sponsor:
Collaborator:
InterMune
Information provided by:
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00266318
First received: December 14, 2005
Last updated: April 16, 2008
Last verified: April 2008
History of Changes
  Purpose

The main purpose of this study is to evaluate the safety and tolerability of combination therapy of daily interferon alfacon-1 (Infergen, CIFN) at high dosage (24 mcg) with ribavirin (based on body weight) for 48 weeks in HCV genotype 1 infected subjects, who are non-responders to previous pegylated interferon alfa plus ribavirin therapy.

This is an open-label, multicenter study. All subjects will receive Infergen 24 mcg administered by injection daily plus ribavirin 800-1400 mg (based on body weight) administered by mouth daily for 48 weeks

* If any 5 of the first 10 subjects can not tolerate the 24 mcg daily dosage of Infergen by week 4, as determined by the principal investigator, then the dosage of Infergen will be changed to 15 mcg administered by injection daily plus ribavirin 800-1400 mg (based on body weight) administered by mouth daily for 48 weeks


Condition Intervention Phase
Hepatitis C
 Drug: Interferon Alfacon-1 and Ribavirin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 4 Open-Label Pilot Study of the Safety and Tolerability of High Dosage of CIFN Plus RBV Administered Daily for 48 Weeks in HCV Genotype 1 Infected Patients Who Are Nonresponders to Prior Pegylated Interferon Alfa Plus RBV Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • *Assessment of safety and tolerability of high dosage Infergen plus ribavirin including adverse events;study medication dose reduction, interruptions, and discontinuations; and BDI-II scores

Secondary Outcome Measures:
  • *Sustained viral response defined as the absence of detectable HCV RNA at week 72

Estimated Enrollment: 40
Study Start Date: December 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must have documented failure to respond to past treatment with a Pegylated IFN + RBV. Failure to respond to past treatment is defined as positive HCV RNA at 12 weeks and less than a 2 log drop from baseline; OR positive HCV RNA and greater than 2 log drop from baseline at week 12 and must have received 24 weeks of therapy and still have a positive HCV RNA
  • Must have tolerated previous hepatitis C therapy
  • Must be off hepatitis C therapy for 3 months prior to study participation
  • Must have had a liver biopsy within the past 5 years

Exclusion Criteria:

  • Decompensated liver disease
  • Laboratory abnormalities as per protocol
  • HIV+
  • Autoimmune disease
  • Unstable or deteriorating cardiovascular or cerebrovascular disease
  • History of seizures in past 5 years
  • Alcohol or drug abuse in past year
  • Pregnant or lactating women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266318

Locations
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
InterMune
Investigators
Principal Investigator: Henry C. Bodenheimer, M.D. Beth Israel Medical Center
  More Information

Publications:
Buggisch P, Seegers B, Hinrichsen H, Hueppe D, Reiser M, de Heer G, et al. 2002. Combination treatment with consensus-interferon and ribavirin for chronic hepatitis C patients with non-response relapse to previous treatment with alpha-interferon and ribavirin. Hepatology 36 (4 pt 2): 363A.
Kaiser S, Hass H, Gregor M. 2002A. high dose induction therapy with consensus interferon and ribavirin for treatment naive patients with hepatitis C. Hepatology 36(4 pt 2): 362A.
Kaiser S, Hass H, gregor M. 2002B. High viral response rates in previous interferon/ribavirin nonresponder patients with chronic hepatitis C retreated with consensus interferon. Hepatology 36(4 pt 2): 358A.
Kaiser S, Hass H, Gregor M. 2003. Successful retreatment of Peginterferon nonresponder patients with chronic hepatitis C with high dose consensus interferon induction therapy. Gastroenterology 124(4):A214.
Cornberg M, Hadem J, Schuppert F, Reiser M, Schmidt H, Marschal O, et al. 2002. Retreatment of hepatitis C nonresponder patients with consensus interferon and ribavirin: a randomized controlled multicenter study. Hepatology 36(4 pt 2): 575A.

ClinicalTrials.gov Identifier: NCT00266318     History of Changes
Other Study ID Numbers: 164-04
Study First Received: December 14, 2005
Last Updated: April 16, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Medical Center:
Hepatitis C Nonresponder
Genotype 1
Interferon Alfacon-1
Consensus Interferon
 CIFN
Infergen
Ribavirin

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

ClinicalTrials.gov processed this record on June 17, 2013