Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Miltefosine for Brazilian Visceral Leishmaniasis

This study has been terminated.
(accrual criteria being reviewed)
Sponsor:
Collaborator:
AEterna Zentaris
Information provided by:
AB Foundation
ClinicalTrials.gov Identifier:
NCT00378495
First received: September 18, 2006
Last updated: January 18, 2011
Last verified: January 2011

September 18, 2006
January 18, 2011
April 2005
April 2007   (final data collection date for primary outcome measure)
cure rate at 6 months
Same as current
Complete list of historical versions of study NCT00378495 on ClinicalTrials.gov Archive Site
  • cure rate at 1 month
  • safety
Same as current
Not Provided
Not Provided
 
Miltefosine for Brazilian Visceral Leishmaniasis
Not Provided

Miltefosine will be administered to Brazilian patients with kala azar

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kala Azar
Drug: Miltefosine: initially 2.5 mg/kg/day for 28 days
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
80
October 2007
April 2007   (final data collection date for primary outcome measure)

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.
Both
2 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00378495
D-18506-Z019
Not Provided
Not Provided
AB Foundation
AEterna Zentaris
Principal Investigator: Reynaldo Dietze Núcleo de Doenças Infecciosas - UFES
AB Foundation
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP