LeishmaniasisNCT02429505
Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
An observational study of Leishmaniasis, run by Knight Therapeutics (USA) Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Leishmaniasis
- What is being tested?
- Miltefosine
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Mar 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: leishmaniasis patients who are administered miltefosine
Who may be able to join
- 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?
Who cannot join
- [none]
Trial locations and contacts
1 site in 1 country.
United States1 site
Fast-Track Drugs and Biologics, LLC
Poolesville, Maryland, 20837
About this study
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.
Read the 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.
- Conditions
- Leishmaniasis
- Being tested
- Miltefosine
- Medical subject headings
- Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiltefosineDrug
Also called Impavido
miltefosine: target 2.5 mg/kg/day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Miltefosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients cured
Determination of possible relationship of lower mg/kg daily doses of miltefosine and efficacy
Measured: 6 months
Secondary outcomes (1)
Number of patients with adverse effects
Adverse events including symptoms and laboratory parameters (if available)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2020
- Study completionMar 2020
Why it stopped: This study was COMPLETED, but no patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Knight Therapeutics (USA) Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janet Ransom, PhD, Principal investigator, Fast Track Drugs and Biologics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429505
- Sponsor's protocol ID
- IMP 2127-4
- Status last verified
- Aug 2020
- First submitted
- 22 Apr 2015
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
- ClinicalTrials.gov ID
- NCT02429505
- Acronym / sponsor ID
- IMP 2127-4
- Conditions
- Leishmaniasis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This study was COMPLETED, but no patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Knight Therapeutics (USA) IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Miltefosine | – | Drug: MiltefosineMiltefosine : 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- leishmaniasis patients who are administered miltefosine
Key inclusion criteria (3 listed)
- 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?
Key exclusion criteria (1 listed)
- [none]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiltefosineAlso: Impavidomiltefosine: target 2.5 mg/kg/day for 28 days | Drug | Miltefosine |
Primary outcome
Number of patients cured
Time frame: 6 months
Determination of possible relationship of lower mg/kg daily doses of miltefosine and efficacy
1 secondary outcome
Number of patients with adverse effects
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Ransom, PhD principal investigator
Fast Track Drugs and Biologics LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leishmaniasis, run by Knight Therapeutics (USA) Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients cured (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.