Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy

April 2, 2015 updated by: Kaiser Permanente

Clofazamine in the Long Term Treatment of Leprosy, Phase III

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92618
        • Kaiser Permanente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

Health Resources and Services Administration (HRSA)

Investigators

  • Principal Investigator: Arnold M Henson, MD, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 26, 2009

First Submitted That Met QC Criteria

February 26, 2009

First Posted (Estimate)

February 27, 2009

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 5347
  • KPSC IRB 5347 (Other Identifier: Kaiser Permanente)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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