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

Leishmaniasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02429505
• Other study ID #: IMP 2127-4
• Status: Withdrawn
• Start date: July 2015
• Est. completion date: March 2020

Study information

• Verified date: August 2020
• Source: Knight Therapeutics (USA) Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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]

Related Conditions & MeSH terms

• Leishmaniasis

Intervention

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

Locations

Country	Name	City	State
United States	Fast-Track Drugs and Biologics, LLC	Poolesville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Knight Therapeutics (USA) Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients cured	Determination of possible relationship of lower mg/kg daily doses of miltefosine and efficacy	6 months
Secondary	Number of patients with adverse effects	Adverse events including symptoms and laboratory parameters (if available)	6 months