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

NCT ID: NCT00266318

Last Updated: 2008-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Hepatitis C

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Interferon Alfacon-1 and Ribavirin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InterMune

INDUSTRY

Sponsor Role collaborator

Beth Israel Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Henry C. Bodenheimer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Medical Center

Locations

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Beth Israel Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

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.

Reference Type RESULT
PMID: 11984144 (View on PubMed)

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.

Reference Type RESULT
PMID: 12375147 (View on PubMed)

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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 15191208 (View on PubMed)

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.

Reference Type RESULT

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.

Reference Type RESULT

Other Identifiers

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164-04

Identifier Type: -

Identifier Source: org_study_id