Clofazamine in the Long Term Treatment of Leprosy, Phase III

Expanded access is currently available for this treatment.

Verified July 2011 by Kaiser Permanente

First Received on February 26, 2009. Last Updated on July 6, 2011 History of Changes

Sponsor:	Kaiser Permanente
Collaborator:	National Hansen's Disease Program
Information provided by:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00852345

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:

MedlinePlus related topics: Mycobacterial Infections

Drug Information available for: Clofazimine

U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Intervention Details:

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 (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

Contacts

Contact: Arnold M Henson, MD

949-932-5116

arnold.m.henson@kp.org

Locations

United States, California
Kaiser Permanente
Irvine, California, United States, 92618
Contact: Arnold M Henson, MD 949-932-5116 arnold.m.henson@kp.org

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:	Barbara Stryjewska/Principal Investigator, National Hansen's Disease Program (NHDP)
ClinicalTrials.gov Identifier:	NCT00852345 History of Changes
Other Study ID Numbers:	IRB 5347
Study First Received:	February 26, 2009
Last Updated:	July 6, 2011
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 February 09, 2012