- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00266318
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
New York
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New York, New York, United States, 10003
- Beth Israel Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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*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
Outcome Measure |
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*Sustained viral response defined as the absence of detectable HCV RNA at week 72
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Henry C. Bodenheimer, M.D., Beth Israel Medical Center
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis
- Hepatitis C
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Interferons
- Ribavirin
- Interferon alfacon-1
Other Study ID Numbers
- 164-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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