LeprosyNCT00852345
Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy
A study testing clofazamine in people with Leprosy, run by Kaiser Permanente at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leprosy
- What is being tested?
- clofazamine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Treatment protocol objective is to treat patients with clofazamine who meet inclusion criteria stated above.
- Conditions
- Leprosy
- Being tested
- clofazamine
- Keywords
- multibacillary leprosy, leprosy, clofazamine
- Medical subject headings
- Leprosy, Leprosy, Multibacillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clofazamineDrug
clofazamine 50mg po qday (duration varies according to physician)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Arnold M Henson, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852345
- Sponsor's protocol ID
- IRB 5347
- Other IDs
- KPSC IRB 5347
- Status last verified
- Mar 2015
- First submitted
- 26 Feb 2009
- Last updated
- 3 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clofazamine in the Long Term Treatment of Leprosy, Phase III
- ClinicalTrials.gov ID
- NCT00852345
- Acronym / sponsor ID
- IRB 5347
- Conditions
- Leprosy
- Keywords
- multibacillary leprosy, leprosy, clofazamine
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clofazamineclofazamine 50mg po qday (duration varies according to physician) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnold M Henson, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clofazamine in people with Leprosy, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.