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Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00852345
First Posted: February 27, 2009
Last Update Posted: April 3, 2015
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.
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Kaiser Permanente
  Purpose
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 Intervention
Leprosy Drug: clofazamine

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

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Intervention Details:
    Drug: clofazamine
    clofazamine 50mg po qday (duration varies according to physician)
Detailed Description:
Treatment protocol objective is to treat patients with clofazamine who meet inclusion criteria stated above.
  Eligibility

Information from the National Library of Medicine

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

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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00852345


Locations
United States, California
Kaiser Permanente
Irvine, California, United States, 92618
Sponsors and Collaborators
Kaiser Permanente
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Arnold M Henson, MD Kaiser Permanente
  More Information

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00852345     History of Changes
Other Study ID Numbers: IRB 5347
KPSC IRB 5347 ( Other Identifier: Kaiser Permanente )
First Submitted: February 26, 2009
First Posted: February 27, 2009
Last Update Posted: April 3, 2015
Last Verified: March 2015

Keywords provided by Kaiser Permanente:
multibacillary leprosy
leprosy
clofazamine

Additional relevant MeSH terms:
Leprosy
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Clofazimine
Anti-Inflammatory Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents