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Clofazamine in the Long Term Treatment of Leprosy, Phase III

Expanded access is temporarily not available for this treatment.
Sponsor:
Collaborator:
National Hansen's Disease Program
Information provided by (Responsible Party):
Arnold M Henson, MD, Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00852345
First received: February 26, 2009
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  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:

Drug Information available for: Clofazimine
U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Intervention Details:
    Drug: clofazamine
    clofazamine 50mg po qday (duration varies according to physician)
    Other Name: clofazamine
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852345

Locations
United States, California
Kaiser Permanente
Irvine, California, United States, 92618
Sponsors and Collaborators
Kaiser Permanente
National Hansen's Disease Program
Investigators
Principal Investigator: Arnold M Henson, MD Kaiser Permanente
  More Information

No publications provided

Responsible Party: Arnold M Henson, MD, Principal Investigator, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00852345     History of Changes
Other Study ID Numbers: IRB 5347
Study First Received: February 26, 2009
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration

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
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013