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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02429505
Other study ID # IMP 2127-4
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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]

Study Design


Related Conditions & MeSH terms


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
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