LeishmaniasisPhase 1/2NCT00373776
Miltefosine for Mucosal Leishmaniasis
A Phase 1/2 study testing miltefosine 2.5 mg/kg/day for 28 days in people with Leishmaniasis, run by AB Foundation at 1 site in Bolivia.
Trial summary
This trial will study miltefosine as a treatment for mucosal leishmaniasis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Leishmaniasis
- What is being tested?
- miltefosine 2.5 mg/kg/day for 28 days
- How many people
- 75 participants
- Where
- 1 siteBolivia
- Study dates
- Apr 2004to May 2006
- Phase
- Phase 1/2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mucosal leishmaniasis
Who cannot join
- Abnormal liver function tests (LFT)
- Abnormal kidney function test
- Concomitant diseases
Trial locations and contacts
1 site in 1 country.
About this study
This trial will study miltefosine as a treatment for mucosal leishmaniasis.
Read the detailed description
Treat bolivian mucosal leishmaniasis with miltefosine.
- Conditions
- Leishmaniasis
- Being tested
- miltefosine 2.5 mg/kg/day for 28 days
- Keywords
- mucosal, leishmaniasis, miltefosine
- Medical subject headings
- Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miltefosine 2.5 mg/kg/day for 28 daysDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Secondary outcomes (1)
toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startApr 2004
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeishmaniasisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- AB Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Jaime soto, MD, Principal investigator, CIBIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373776
- Sponsor's protocol ID
- 04--01
- Status last verified
- Sep 2006
- First submitted
- 7 Sep 2006
- Last updated
- 8 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miltefosine for Mucosal Leishmaniasis
- ClinicalTrials.gov ID
- NCT00373776
- Acronym / sponsor ID
- 04--01
- Conditions
- Leishmaniasis
- Keywords
- mucosal, leishmaniasis, miltefosine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- AB FoundationUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- May 2006
- First posted
- 8 Sep 2006 (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.
This trial will study miltefosine as a treatment for mucosal leishmaniasis.
Detailed description
Treat bolivian mucosal leishmaniasis with miltefosine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mucosal leishmaniasis
Key exclusion criteria (3 listed)
- Abnormal liver function tests (LFT)
- Abnormal kidney function test
- Concomitant diseases
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 |
|---|---|---|
| miltefosine 2.5 mg/kg/day for 28 days | Drug | – |
Primary outcome
Efficacy
1 secondary outcome
toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2006.
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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.
Jaime soto, MD principal investigator
CIBIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing miltefosine 2.5 mg/kg/day for 28 days in people with Leishmaniasis, run by AB Foundation at 1 site in Bolivia.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 8 Sep 2006. 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 Bolivia. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Efficacy. It is what the study was designed to measure, not a finding.
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 8 Sep 2006.