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Miltefosine to Treat Mucocutaneous Leishmaniasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01050907
First Posted: January 18, 2010
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Knight Therapeutics (USA) Inc
  Purpose

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.


Condition Intervention Phase
Mucosal Leishmaniasis Cutaneous Leishmaniasis Drug: miltefosine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Mucocutaneous Leishmaniasis With Miltefosine

Resource links provided by NLM:


Further study details as provided by Knight Therapeutics (USA) Inc:

Primary Outcome Measures:
  • cure rate at the end of follow up [ Time Frame: 6 months (CL) and 12 months (ML) post therapy ]

Secondary Outcome Measures:
  • symptomatic adverse effects: gastrointestinal [ Time Frame: days 1-28 of therapy ]
  • laboratory adverse effects: creatinine or LFT elevation [ Time Frame: days 1-28 of therapy ]

Enrollment: 4
Study Start Date: May 2010
Study Completion Date: March 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: miltefosine Drug: miltefosine
2.5 mg/kg/day for 28 days

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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?
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050907


Locations
United States, Maryland
for this treatment IND, each Physician will enter patients at his/her own facility. Below data is for Protocol central contact
Bethesda, Maryland, United States, 20852
NIH
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Knight Therapeutics (USA) Inc
Investigators
Principal Investigator: Jonathan Berman, MD Fast Track Drugs and Biologics LLC
  More Information

Responsible Party: Knight Therapeutics (USA) Inc
ClinicalTrials.gov Identifier: NCT01050907     History of Changes
Other Study ID Numbers: PAL-MILT-201
First Submitted: January 12, 2010
First Posted: January 18, 2010
Last Update Posted: March 25, 2015
Last Verified: January 2011

Keywords provided by Knight Therapeutics (USA) Inc:
leishmaniasis
cutaneous disease
mucosal disease
miltefosine

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Leishmaniasis, Mucocutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Miltefosine
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents