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