Kala AzarPhase 1/2NCT00378495
Miltefosine for Brazilian Visceral Leishmaniasis
A Phase 1/2 study testing Miltefosine: initially 2.5 mg/kg/day for 28 days in people with Kala Azar, run by AB Foundation at 1 site in Brazil.
Trial summary
Miltefosine will be administered to Brazilian patients with kala azar Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Kala Azar
- What is being tested?
- Miltefosine: initially 2.5 mg/kg/day for 28 days
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2005to Oct 2007
- 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 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed (untreated) visceral leishmaniasis with symptomatic disease and visualization of amastigotes in tissue samples or a positive culture.
- Age: Group 1: 2 to 12 years; Group 2: 13 to 60 years
- Sex: male and female patients eligible (no effort to be made to balance the study for gender)
Who cannot join
- Safety concerns:
- Thrombocyte count <30 x 109/l;
- Leukocyte count <1 x 109/l;
- Hemoglobin <5 g/100 ml;
- ASAT, ALAT, AP >3 times upper limit of normal range;
- Serum creatinine or BUN >1.5 times upper limit of normal range;
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- Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary);
- Immunodeficiency or antibody to HIV;
- Severe protein and/or caloric malnutrition (Kwashiorkor, Marasmus);
- Any non-compensated or uncontrolled condition;
- Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months.
- Lack of suitability for the trial:
- Negative bone marrow aspirate (smear);
- Any history of prior anti-leishmania therapy;
- Any condition which compromises ability to comply with the study procedures;
- Concomitant serious infection other than visceral leishmaniasis (this would include evidence of other conditions associated with splenomegaly such as schistosomiasis or malaria).
- Administrative reasons:
- Lack of ability or willingness to give informed consent (patient and/or parent / legal representative);
- Anticipated non-availability for study visits/procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Miltefosine will be administered to Brazilian patients with kala azar
Read the detailed description
Miltefosine will be administered to Brazilian patients with kala azar. Both pediatric and adult patients will be studied. Patients will be followed for 6 months.
- Conditions
- Kala Azar
- Being tested
- Miltefosine: initially 2.5 mg/kg/day for 28 days
- Keywords
- miltefosine, kala azar, Brazil
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miltefosine: initially 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.
cure rate at 6 months
Secondary outcomes (2)
cure rate at 1 month
safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2006 (estimated)
- Study startApr 2005
- Primary completionApr 2007
- Study completionOct 2007
Why it stopped: accrual criteria being reviewed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kala AzarStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AB Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- AEterna Zentaris
- Investigators
- Reynaldo Dietze, Principal investigator, Núcleo de Doenças Infecciosas - UFES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378495
- Sponsor's protocol ID
- D-18506-Z019
- Status last verified
- Jan 2011
- First submitted
- 18 Sep 2006
- Last updated
- 12 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miltefosine for Brazilian Visceral Leishmaniasis
- ClinicalTrials.gov ID
- NCT00378495
- Acronym / sponsor ID
- D-18506-Z019
- Conditions
- Kala Azar
- Keywords
- miltefosine, kala azar, Brazil
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: accrual criteria being reviewed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- AB FoundationUniversity, hospital or other
- Collaborators
- AEterna Zentaris
- Study start
- Apr 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 20 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.
Miltefosine will be administered to Brazilian patients with kala azar
Detailed description
Miltefosine will be administered to Brazilian patients with kala azar. Both pediatric and adult patients will be studied. Patients will be followed for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed (untreated) visceral leishmaniasis with symptomatic disease and visualization of amastigotes in tissue samples or a positive culture.
Key exclusion criteria (19 listed)
- Thrombocyte count <30 x 109/l;
- Leukocyte count <1 x 109/l;
- Hemoglobin <5 g/100 ml;
- ASAT, ALAT, AP >3 times upper limit of normal range;
- Serum creatinine or BUN >1.5 times upper limit of normal range;
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: initially 2.5 mg/kg/day for 28 days | Drug | – |
Primary outcome
cure rate at 6 months
2 secondary outcomes
cure rate at 1 month
safety
Results and safety
The study was stopped early (reason given: accrual criteria being reviewed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
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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.
Reynaldo Dietze principal investigator
Núcleo de Doenças Infecciosas - UFES
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: initially 2.5 mg/kg/day for 28 days in people with Kala Azar, run by AB Foundation at 1 site in Brazil.
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 3 inclusion and 19 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: stopped early, as of the sponsor's last update on 12 Jul 2016. 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 Brazil. 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 was stopped early (reason given: accrual criteria being reviewed). 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.
What does the primary outcome measure?
cure rate at 6 months. 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 12 Jul 2016.