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Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy

Primary Purpose

Leprosy

Status

No longer available

Phase

Locations

United States

Study Type

Expanded Access

Intervention

clofazamine

About this trial

This is an expanded access trial for Leprosy focused on measuring multibacillary leprosy, leprosy, clofazamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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)

Sites / Locations

Kaiser Permanente

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00852345

First Posted

February 26, 2009

Last Updated

April 2, 2015

Sponsor

Kaiser Permanente

Collaborators

Health Resources and Services Administration (HRSA)

1. Study Identification

Unique Protocol Identification Number

NCT00852345

Brief Title

Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy

Official Title

Clofazamine in the Long Term Treatment of Leprosy, Phase III

Study Type

Expanded Access

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

No longer available

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kaiser Permanente

Collaborators

Health Resources and Services Administration (HRSA)

4. Oversight

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leprosy

Keywords

multibacillary leprosy, leprosy, clofazamine

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

clofazamine

Intervention Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnold M Henson, MD

Organizational Affiliation

Kaiser Permanente

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaiser Permanente

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy

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