Clinical trial NCT02429505: Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
Official title: Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Leishmaniasis
Lead sponsor: Knight Therapeutics (USA) Inc
Sponsor class: INDUSTRY
First posted: 2015-04-29
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: leishmaniasis patients who are administered miltefosine

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.

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.

Eligibility 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:

\[none\]

Primary outcomes:
measure: Number of patients cured
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients with adverse effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Poolesville
country: United States
facility: Fast-Track Drugs and Biologics, LLC
state: Maryland
Study officials:
affiliation: Fast Track Drugs and Biologics LLC
name: Janet Ransom, PhD
role: PRINCIPAL_INVESTIGATOR
References: