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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266318
• Other study ID #: 164-04
• Status: Completed
• Phase: Phase 4
• First received: December 14, 2005
• Last updated: April 16, 2008
• Start date: December 2005
• Est. completion date: May 2007

Study information

• Verified date: April 2008
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• Interferon Alfacon-1 and Ribavirin

Locations

Country	Name	City	State
United States	Beth Israel Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Medical Center	InterMune

Country where clinical trial is conducted

United States, 

References & Publications (7)

Barbaro G, Barbarini G. Consensus interferon for chronic hepatitis C patients with genotype 1 who failed to respond to, or relapsed after, interferon alpha-2b and ribavirin in combination: an Italian pilot study. Eur J Gastroenterol Hepatol. 2002 May;14(5 — View Citation

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 ribav

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.

da Silva LC, Bassit L, Ono-Nita SK, Pinho JR, Nishiya A, Madruga CL, Carrilho FJ. High rate of sustained response to consensus interferon plus ribavirin in chronic hepatitis C patients resistant to alpha-interferon and ribavirin: a pilot study. J Gastroen — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	*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	*Sustained viral response defined as the absence of detectable HCV RNA at week 72