Miltefosine for Brazilian Visceral Leishmaniasis

Kala Azar Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00378495
• Other study ID #: D-18506-Z019
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 18, 2006
• Last updated: July 11, 2016
• Start date: April 2005
• Est. completion date: October 2007

Study information

• Verified date: January 2011
• Source: AB Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Miltefosine will be administered to Brazilian patients with kala azar

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: October 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

Exclusion criteria

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;

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kala Azar
• Leishmaniasis
• Leishmaniasis, Visceral

Intervention

Drug:
• Miltefosine: initially 2.5 mg/kg/day for 28 days

Locations

Country	Name	City	State
Brazil	Universidade Estadual de Montes Claros	Montes Claros

Sponsors (2)

Lead Sponsor	Collaborator
AB Foundation	AEterna Zentaris

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cure rate at 6 months
Secondary	cure rate at 1 month
Secondary	safety