Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy

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Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00852345
First received: February 26, 2009
Last updated: April 2, 2015
Last verified: March 2015

February 26, 2009
April 2, 2015
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Complete list of historical versions of study NCT00852345 on ClinicalTrials.gov Archive Site
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Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy
Clofazamine in the Long Term Treatment of Leprosy, Phase III
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 treatment of multibacillary leprosy. In recent years, the availability of the drug has become limited and is currently available only under a research protocol and is considered "investigational." Use of Clofazamine in patients presenting with lepromatous leprosy is necessary for patients exhibiting nerve involvement or lesions resistant to other therapies. This drug will be used prospectively for patients who require treatment of leprosy as deemed appropriate by a Kaiser Permanente Southern California physician.
Treatment protocol objective is to treat patients with clofazamine who meet inclusion criteria stated above.
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Leprosy
Drug: clofazamine
clofazamine 50mg po qday (duration varies according to physician)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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Inclusion Criteria:

  • 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 Criteria:

  • 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)
Both
18 Years and older   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00852345
IRB 5347, KPSC IRB 5347
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Kaiser Permanente
Kaiser Permanente
Health Resources and Services Administration (HRSA)
Principal Investigator: Arnold M Henson, MD Kaiser Permanente
Kaiser Permanente
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP