Treatment of Leishmaniasis With Impavido® (Miltefosine):... | NCT02429505

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

NCT02429505

Sponsor

Knight Therapeutics (USA) Inc

Status

Withdrawn

Last Update Posted

Aug 28, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Leishmaniasis

Interventions

Miltefosine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was COMPLETED, but no patients were enrolled.

Expanded Access Info

Start Date

Jul 2015Actual

Primary Completion Date

Mar 2020Actual

Completion Date

Mar 2020Actual

First Submitted Date

Apr 22, 2015

First Submission Date that Met QC Criteria

Apr 24, 2015

First Posted Date

Apr 29, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2020

Last Update Posted Date

Aug 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Miltefosine		Miltefosine : target of 2.5 mg/kg/day for 28 days. Patients 45 kg or greater were to receive one 50 mg capsule 3 times daily for 28 consecutive days. This prospective observational study in which patients undergoing treatment for leishmaniasis with miltefosine in the United States who weighed >75 kg could volunteer to provide information about their clinical response to treatment up to 6 months after the start of treatment.	Drug: Miltefosine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Miltefosine	Drug	miltefosine: target 2.5 mg/kg/day for 28 days	Miltefosine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients cured	Determination of possible relationship of lower mg/kg daily doses of miltefosine and efficacy	6 months

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with adverse effects	Adverse events including symptoms and laboratory parameters (if available)	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Did the subject give consent to collect data from her or her physician?
Was the subject treated for leishmaniasis with miltefosine?
Does the subject weigh more than 75 kg?

Exclusion Criteria:

[none]

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

leishmaniasis patients who are administered miltefosine

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janet Ransom, PhD	Fast Track Drugs and Biologics LLC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fast-Track Drugs and Biologics, LLC		Poolesville	Maryland	20837	United States

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 30, 2014	Aug 20, 2020	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D007896	Leishmaniasis

Ancestor Terms

ID	Term
D056986	Euglenozoa Infections
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C039128	miltefosine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided