NCT02429505

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

4.7 years

First QC Date

April 22, 2015

Last Update Submit

August 26, 2020

Conditions

Leishmaniasis

Outcome Measures

Primary Outcomes (1)

  • Number of patients cured

    Determination of possible relationship of lower mg/kg daily doses of miltefosine and efficacy

    6 months

Secondary Outcomes (1)

  • Number of patients with adverse effects

    6 months

Study Arms (1)

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

MiltefosineDRUG

miltefosine: target 2.5 mg/kg/day for 28 days

Also known as: Impavido
Miltefosine

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

leishmaniasis patients who are administered miltefosine

You may qualify if:

  • 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?

You may not qualify if:

  • \[none\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fast-Track Drugs and Biologics, LLC

Poolesville, Maryland, 20837, United States

Location

MeSH Terms

Conditions

Leishmaniasis

Interventions

miltefosine

Condition Hierarchy (Ancestors)

Euglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Janet Ransom, PhD

    Fast Track Drugs and Biologics LLC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2015

First Posted

April 29, 2015

Study Start

July 1, 2015

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

August 28, 2020

Record last verified: 2020-08

Locations

US(1)