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CompletedNCT00266318Updated Apr 17, 2008

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

A Phase 4 interventional study of Interferon Alfacon-1 and Ribavirin in Hepatitis C, sponsored by Beth Israel Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-04-17.

Sponsored by Beth Israel Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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

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Conditions studied

  • Hepatitis C

Keywords

  • Hepatitis C Nonresponder
  • Genotype 1
  • Interferon Alfacon-1
  • Consensus Interferon
  • CIFN
  • Infergen
  • Ribavirin
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In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 40 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Beth Israel Medical Center is the lead sponsor of 50 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants

Interventions

  • DrugInterferon Alfacon-1 and Ribavirin
06

What researchers measure

Primary outcomes

  1. *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 outcomes

  1. *Sustained viral response defined as the absence of detectable HCV RNA at week 72

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Study locations

1 site
  • Beth Israel Medical Center
    New York, New York 10003, United States
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References and documents

Publications

  • 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.
  • 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):477-83. doi: 10.1097/00042737-200205000-00003. PubMed 11984144 ↗
  • 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 Gastroenterol. 2002;37(9):732-6. doi: 10.1007/s005350200119. PubMed 12375147 ↗
  • 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.
  • Hass HG, Nehls O, Gregor M, Kaiser S, Kreysel C. Treatment of chronic hepatitis C in naive patients with high-dose interferon-alpha2a induction therapy and two different ribavirin doses. Dig Liver Dis. 2004 May;36(5):367-8. doi: 10.1016/j.dld.2004.01.009. No abstract available. PubMed 15191208 ↗
  • 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.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00266318
Lead sponsor
Beth Israel Medical Center
Collaborators
InterMune
First posted
Dec 16, 2005
Start date
Dec 2005
Primary completion
May 2007
Completion
May 2007
Last update
Apr 17, 2008

Study contacts

Henry C. Bodenheimer, M.D.
principal investigator · Beth Israel Medical Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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