Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy

Leprosy Clinical Trial

Official title:

Clofazamine in the Long Term Treatment of Leprosy, Phase III

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00852345
• Other study ID #: IRB 5347
• Secondary ID: KPSC IRB 5347
• Status: No longer available
• Phase: N/A
• First received: February 26, 2009
• Last updated: April 2, 2015

Study information

• Verified date: March 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Expanded Access

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

N/A

Related Conditions & MeSH terms

• Leprosy

Intervention

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

Locations

Country	Name	City	State
United States	Kaiser Permanente	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States,