NCT00852345

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
Last Updated

April 3, 2015

Status Verified

March 1, 2015

First QC Date

February 26, 2009

Last Update Submit

April 2, 2015

Conditions

Leprosy

Keywords

multibacillary leprosyleprosyclofazamine

Interventions

clofazamineDRUG

clofazamine 50mg po qday (duration varies according to physician)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

LeprosyLeprosy, Multibacillary

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Arnold M Henson, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2009

First Posted

February 27, 2009

Last Updated

April 3, 2015

Record last verified: 2015-03

Locations

US(1)