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

December 14, 2005
April 16, 2008
December 2005
May 2007   (final data collection date for primary outcome measure)
*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
Same as current
Complete list of historical versions of study NCT00266318 on ClinicalTrials.gov Archive Site
*Sustained viral response defined as the absence of detectable HCV RNA at week 72
Same as current
Not Provided
Not Provided
 
Study of High Dosage CIFN Plus RBV for HCV Genotype 1 Infected Patients Who Are Nonresponders to Prior Therapy
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

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
Drug: Interferon Alfacon-1 and Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00266318
164-04
Not Provided
Not Provided
Beth Israel Medical Center
InterMune
Principal Investigator: Henry C. Bodenheimer, M.D. Beth Israel Medical Center
Beth Israel Medical Center
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP