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Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry

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ClinicalTrials.gov Identifier: NCT02429505
Recruitment Status : Withdrawn (This study was COMPLETED, but no patients were enrolled.)
First Posted : April 29, 2015
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Knight Therapeutics (USA) Inc

Brief Summary:
This study is a prospective observational study in which patients undergoing treatment for leishmaniasis with miltefosine (Impavido) in the US and who weigh > 75 kg can volunteer to provide information about their clinical response to treatment up to 6 months after the start of treatment.

Condition or disease Intervention/treatment
Leishmaniasis Drug: Miltefosine

Detailed Description:

Objective: The purpose of this observational study is to fulfill PMR 2127-4 for the miltefosine NDA (204684): implement a higher-weight-patient registry for the time period Mar 2015-Mar 2020.

Study Design: This study is a prospective observational study in which patients undergoing treatment for leishmaniasis with Impavido in the US and who weigh > 75 kg can volunteer to provide information about their clinical response to treatment up to 6 months after the start of treatment.

Population: Leishmaniasis patients treated with Impavido who weigh more than 75 kg.

Drug Product:

Drug name: Impavido (50 mg capsules). Dosing regimen: as per the Impavido Product Label

Study Procedures: Patients who weigh more than 75 kg will become aware of the Impavido Higher-Weight Patient Registry via the Impavido website. By calling 1-866-588-5405, the patient will be connected to the Impavido Higher-Weight Patient Registry Coordinating Center. A trained staff member will acquaint the patient with the goals and procedures of the study. If the patient tentatively agrees to participate in the study over the telephone, the patient will be mailed information forms, the Consent/Assent Forms, and the Consent for the patient's physician to release medical information. Receipt of the two signed Consent and/or Assent Forms by the Coordinating Center will signify patient consent. The Coordinating Center will contact the patient's physician at the end of treatment, and at 1, 3, and 6 months after completing treatment, to collect data on efficacy and adverse effects (only during treatment).

Sample Size and Study Duration: Estimated 3-10 patients per year for 5 years.

Outcome Parameters:

Efficacy Adverse effects

Analysis: Baseline data, compliance to prescribed treatment, and outcomes will be reported for individual patients and for all patients.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
Actual Study Start Date : July 2015
Actual Primary Completion Date : March 2020
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Miltefosine

Group/Cohort Intervention/treatment
Miltefosine
Miltefosine : target of 2.5 mg/kg/day for 28 days. Patients 45 kg or greater were to receive one 50 mg capsule 3 times daily for 28 consecutive days. This prospective observational study in which patients undergoing treatment for leishmaniasis with miltefosine in the United States who weighed >75 kg could volunteer to provide information about their clinical response to treatment up to 6 months after the start of treatment.
Drug: Miltefosine
miltefosine: target 2.5 mg/kg/day for 28 days
Other Name: Impavido




Primary Outcome Measures :
  1. Number of patients cured [ Time Frame: 6 months ]
    Determination of possible relationship of lower mg/kg daily doses of miltefosine and efficacy


Secondary Outcome Measures :
  1. Number of patients with adverse effects [ Time Frame: 6 months ]
    Adverse events including symptoms and laboratory parameters (if available)



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.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
leishmaniasis patients who are administered miltefosine
Criteria

Inclusion Criteria:

  1. Did the subject give consent to collect data from her or her physician?
  2. Was the subject treated for leishmaniasis with miltefosine?
  3. Does the subject weigh more than 75 kg?

Exclusion Criteria:

[none]


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): NCT02429505


Locations
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United States, Maryland
Fast-Track Drugs and Biologics, LLC
Poolesville, Maryland, United States, 20837
Sponsors and Collaborators
Knight Therapeutics (USA) Inc
Investigators
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Principal Investigator: Janet Ransom, PhD Fast Track Drugs and Biologics LLC
  Study Documents (Full-Text)

Documents provided by Knight Therapeutics (USA) Inc:
Study Protocol  [PDF] December 30, 2014

Additional Information:

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Responsible Party: Knight Therapeutics (USA) Inc
ClinicalTrials.gov Identifier: NCT02429505    
Other Study ID Numbers: IMP 2127-4
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Leishmaniasis
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