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Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00852345
Expanded Access Status : No longer available
First Posted : February 27, 2009
Last Update Posted : April 3, 2015
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Kaiser Permanente

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 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.

Condition or disease Intervention/treatment
Leprosy Drug: clofazamine

Detailed Description:
Treatment protocol objective is to treat patients with clofazamine who meet inclusion criteria stated above.

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Study Type : Expanded Access
Official Title: Clofazamine in the Long Term Treatment of Leprosy, Phase III

Intervention Details:
  • Drug: clofazamine
    clofazamine 50mg po qday (duration varies according to physician)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00852345

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United States, California
Kaiser Permanente
Irvine, California, United States, 92618
Sponsors and Collaborators
Kaiser Permanente
Health Resources and Services Administration (HRSA)
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Principal Investigator: Arnold M Henson, MD Kaiser Permanente
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Responsible Party: Kaiser Permanente Identifier: NCT00852345    
Other Study ID Numbers: IRB 5347
KPSC IRB 5347 ( Other Identifier: Kaiser Permanente )
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: March 2015
Keywords provided by Kaiser Permanente:
multibacillary leprosy
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Inflammatory Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents