Status:
NO_LONGER_AVAILABLE
Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Health Resources and Services Administration (HRSA)
Conditions:
Leprosy
Eligibility:
All Genders
18+ years
Brief Summary
Clofazimine has shown effectiveness in the treatment of leprosy for many years. The World Health Organization and the National Hansen's Disease Program consider clofazamine to be standard therapy for ...
Detailed Description
Treatment protocol objective is to treat patients with clofazamine who meet inclusion criteria stated above.
Eligibility Criteria
Inclusion
- Known or suspected leprosy confirmed by skin biopsy and/or slit skin smears.
- Multibacillary leprosy (lepromatous leprosy or borderline-lepromatous).
- Paucibacillary leprosy (borderline, borderline tuberculoid, or indeterminate) if there is involvement of the cranial nerves or active acute neuritis.
- Known or suspected ENL(erythema nodosum leprosum) (a specific immune reaction with painful skin nodules and fever)
- Known or suspected dapsone-resistant leprosy or relapsed leprosy.
- Intolerance of other antileprosy antibiotic (where clofazamine is substituted as apart of multidrug regimen)
Exclusion
- Uncomplicated paucibacillary leprosy which would otherwise be treated with dapsone and rifampin only.
- Known prior intolerance of Clofazamine
- Any minor (even with parental consent)
- Any fertile woman who is pregnant a specific immune reaction with painful skin rash and fever)
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00852345
Last Update
April 3 2015
Active Locations (1)
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1
Kaiser Permanente
Irvine, California, United States, 92618