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

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.

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]