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Miltefosine to Treat Mucocutaneous Leishmaniasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Knight Therapeutics (USA) Inc
ClinicalTrials.gov Identifier:
NCT01050907
First received: January 12, 2010
Last updated: March 24, 2015
Last verified: January 2011

January 12, 2010
March 24, 2015
May 2010
February 2015   (final data collection date for primary outcome measure)
cure rate at the end of follow up [ Time Frame: 6 months (CL) and 12 months (ML) post therapy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01050907 on ClinicalTrials.gov Archive Site
  • symptomatic adverse effects: gastrointestinal [ Time Frame: days 1-28 of therapy ] [ Designated as safety issue: Yes ]
  • laboratory adverse effects: creatinine or LFT elevation [ Time Frame: days 1-28 of therapy ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Miltefosine to Treat Mucocutaneous Leishmaniasis
Treatment of Mucocutaneous Leishmaniasis With Miltefosine

The purpose of this Treatment IND is to make miltefosine available for mucocutaneous leishmaniasis patients presenting in the United States.

If entrance criteria are met, subjects with mucosal or cutaneous leishmaniasis will receive miltefosine at a targeted dose of 2.5 mg/kg/day for 28 days. During treatment at weeks 1, 2, and 4, the patient will return to the treatment facility to be assessed for adverse events. Blood for transaminase and creatinine values will be drawn at the midpoint and at the end of therapy.

Patients will return to the treatment facility to be examined clinically at 6 wks (ie, 2 wks after the end of therapy), 3 months (2 months after therapy), and 7 months (6 months after treatment) for ML and CL patients, and also at 13 months (12 months after treatment) for ML patients.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Mucosal Leishmaniasis
  • Cutaneous Leishmaniasis
Drug: miltefosine
2.5 mg/kg/day for 28 days
Experimental: miltefosine
Intervention: Drug: miltefosine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
March 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Is the subject a male or female at least 18 years of age?
  2. Does the subject weigh at least 30 kg?
  3. Does the subject have a diagnosis of ML or CL in at least one lesion by at least one of the following methods: 1) positive culture for promastigotes of lesion material, 2) microscopic identification of amastigotes in stained lesion tissue, 3) PCR of lesion material?
  4. In the opinion of the investigator, is the subject capable of understanding and complying with the protocol?
  5. If female and of child-bearing potential, did the subject have a negative pregnancy test during screening and agree to use an acceptable method of birth control during the treatment phase and for 6 months after treatment is completed?
  6. Has the patient signed informed consent?

Exclusion Criteria:

  1. Is the subject a female who is breast-feeding?
  2. Does the subject have a clinically significant medical disorder?

    • Thrombocyte count <100 x 109/l
    • Leukocyte count <3 x 109/l
    • Haemoglobin <10 g/100 ml
    • ASAT, ALAT >2 times upper limit of normal range
    • Bilirubin >1.5 times upper limit of normal range
    • Serum creatinine >1.5 times upper limit of normal range
    • Major surgery within last 2 weeks
    • Any non-compensated or uncontrolled condition
  3. In the last 4 weeks up to the present, has the subject received other treatment for leishmaniasis, including any medication with pentavalent antimony; amphotericin B, paromomycin, or imidazoles?
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01050907
PAL-MILT-201
No
Not Provided
Not Provided
Knight Therapeutics (USA) Inc
Knight Therapeutics (USA) Inc
Not Provided
Principal Investigator: Jonathan Berman, MD Fast Track Drugs and Biologics LLC
Knight Therapeutics (USA) Inc
January 2011

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