Mucocutaneous LeishmaniasisNCT02429518
Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
An observational study of Mucocutaneous Leishmaniasis, run by Knight Therapeutics (USA) Inc at 1 site in Bolivia.
Trial summary
This study is a Phase 4, open-label, single group study in which at least 40 adult patients undergoing miltefosine treatment for mucocutaneous leishmaniasis (CL and ML) will be assessed by 12-lead ECG for prolongation of the corrected QT interval Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Mucocutaneous Leishmaniasis
- What is being tested?
- Miltefosine
- How many people
- 42 participants
- Where
- 1 siteBolivia
- Study dates
- Dec 2015to 6 Mar 2018
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Persons with mucocutaneous leishmaniasis being treated with miltefosine
Who may be able to join
- Provide written informed consent
- Be available to complete study procedures
- Have a diagnosis of mucocutaneous leishmaniasis confirmed by microscopy of a stained smear of a lesion sample, by culture of a lesion sample, or by polymerase chain reaction (PCR) of a lesion sample or by Montenegro skin test and be willing to undergo treatment with miltefosine
- Be male or female and 18-55 years of age
- Have alanine aminotransferase (ALT), total bilirubin, and creatinine < 1.5 x upper upper limit of normal (ULN)
- Have white blood cell (WBC) count, hemoglobin, and platelet count within 15% of within normal limits (WNL)
Show all 12Show fewer
- Be without clinically significant non-cardiac medical disorder
- Have 12-lead corrected QT interval using the Fridericia method (QTcF) interval < 450 msec, abnormal heart rate (< 40 or > 120 beats/min), PR interval (from 131 msec to 197 msec for males and 120 msec to 196 msec for females, or QRS interval (from 78 msec to 126 msec for males and 74 msec to 114 msec for females)
- Have blood levels of ions that might affect ECG: (magnesium 1.82 mg/dL to 2.41 mg/dL, calcium 8.5 mg/dL to 10.5 mg/dL, potassium 3.5 milliequivalents/liter (mEq/L) to 10.5 mEq/L, and sodium 135 mEq/L to 148 mEq/L)
- Have no family history of sudden cardiac death before age 40
- Have no personal history ischemic heart disease, congestive heart failure, palpitations, dizziness, syncope, cardiac arrhythmias
- If female, agree to use an effective method of birth control from the start of treatment until 5 months after completing treatment and have a negative pregnancy test
Who cannot join
- Be a female who is breast feeding
- Be a female who is pregnant
- In the past 28 days prior to the start of miltefosine treatment have received any drug or other treatment that is known to significantly affect the QTc interval
- Have positive serology for Chagas disease
Trial locations and contacts
1 site in 1 country.
About this study
This study is a Phase 4, open-label, single group study in which at least 40 adult patients undergoing miltefosine treatment for mucocutaneous leishmaniasis (CL and ML) will be assessed by 12-lead ECG for prolongation of the corrected QT interval
Read the detailed description
This study is a Phase 4, open-label, single group study in which at least 40 adult patients undergoing miltefosine treatment for mucocutaneous leishmaniasis will be assessed by digital 12-lead electrocardiogram (ECG) for prolongation of the corrected QT (QTc) interval. Potential subjects diagnosed with mucocutaneous leishmaniasis who are planning to undergo miltefosine treatment will be informed about the study and undergo the informed consent process. After obtaining informed consent, subjects will be screened over a 14-day period for eligibility by medical history including leishmaniasis diagnostics, physical examination, clinical laboratory measurements [chemistries: alanine aminotransferase (ALT), total bilirubin, creatinine, magnesium, calcium, potassium, sodium; hematology: white blood cell (WBC) count, hemoglobin, platelet count; and a pregnancy test if female], ECG, and medication use in the 28-day period before starting treatment. If eligible for the study, the subject will receive miltefosine for 28 days at a target dose of approximately 2.5 mg/kg/day. Screening and enrollment into the study will continue until at least 10 females and up to 30 males complete the study and are considered evaluable (provide Day 28 ECGs and pharmacokinetic (PK) samples and complete at least 25 of 28 days of miltefosine treatment). Vital signs will be collected weekly during treatment. Chemistries and hematology will be repeated at study Days 14 (mid-treatment) and 28 (end of treatment). A pregnancy test (if applicable) will be repeated at Day 28. ECGs (12-lead) will be repeated at Days 14 and 28. Blood will be drawn for PK assessments on Days 14 and 28 within 15 minutes of the final ECG. Adverse events (AEs) and concomitant medication use will be collected during treatment. If on Day 28, clinically significant abnormalities are observed by ECG, then a repeat ECG and PK blood draw will be performed at Day 42 (2 weeks after completing treatment). AEs and concomitant medication use will also be collected in any subject coming back for the Day 42 visit. Digital ECGs (12-lead) will be collected in triplicate at each time point over a period not to exceed 1 hour. During treatment, ECGs will be collected 4 hours after a dose (approximate Tmax).
- Conditions
- Mucocutaneous Leishmaniasis
- Being tested
- Miltefosine
- Keywords
- leishmaniasis, miltefosine, EKG
- Medical subject headings
- Leishmaniasis, Mucocutaneous, Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiltefosineDrug
Also called Impavido
| Study group | Role | What they receive |
|---|---|---|
| Miltefosine | Miltefosine: target of 2.5 mg/kg/day for 28 days Receives: Drug: Miltefosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean value of corrected QT interval
QTcF
Measured: up to 2 weeks after end of treatment
Secondary outcomes (1)
number of patients with adverse events
AEs and SAEs
Measured: up to 2 months after end of treatment
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 startDec 2015
- Primary completion6 Jun 2017
- Study completion6 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucocutaneous 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Knight Therapeutics (USA) Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaime Soto, MD, Principal investigator, Fundacion Nacional de Dermatologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429518
- Sponsor's protocol ID
- MILT 2127-3
- Status last verified
- Mar 2019
- First submitted
- 22 Apr 2015
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
- ClinicalTrials.gov ID
- NCT02429518
- Acronym / sponsor ID
- MILT 2127-3
- Conditions
- Mucocutaneous Leishmaniasis
- Keywords
- leishmaniasis, miltefosine, EKG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Knight Therapeutics (USA) IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 6 Mar 2018 (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 Phase 4, open-label, single group study in which at least 40 adult patients undergoing miltefosine treatment for mucocutaneous leishmaniasis (CL and ML) will be assessed by 12-lead ECG for prolongation of the corrected QT interval
Detailed description
This study is a Phase 4, open-label, single group study in which at least 40 adult patients undergoing miltefosine treatment for mucocutaneous leishmaniasis will be assessed by digital 12-lead electrocardiogram (ECG) for prolongation of the corrected QT (QTc) interval. Potential subjects diagnosed with mucocutaneous leishmaniasis who are planning to undergo miltefosine treatment will be informed about the study and undergo the informed consent process. After obtaining informed consent, subjects will be screened over a 14-day period for eligibility by medical history including leishmaniasis diagnostics, physical examination, clinical laboratory measurements [chemistries: alanine aminotransferase (ALT), total bilirubin, creatinine, magnesium, calcium, potassium, sodium; hematology: white blood cell (WBC) count, hemoglobin, platelet count; and a pregnancy test if female], ECG, and medication use in the 28-day period before starting treatment. If eligible for the study, the subject will receive miltefosine for 28 days at a target dose of approximately 2.5 mg/kg/day. Screening and enrollment into the study will continue until at least 10 females and up to 30 males complete the study and are considered evaluable (provide Day 28 ECGs and pharmacokinetic (PK) samples and complete at least 25 of 28 days of miltefosine treatment). Vital signs will be collected weekly during treatment. Chemistries and hematology will be repeated at study Days 14 (mid-treatment) and 28 (end of treatment). A pregnancy test (if applicable) will be repeated at Day 28. ECGs (12-lead) will be repeated at Days 14 and 28. Blood will be drawn for PK assessments on Days 14 and 28 within 15 minutes of the final ECG. Adverse events (AEs) and concomitant medication use will be collected during treatment. If on Day 28, clinically significant abnormalities are observed by ECG, then a repeat ECG and PK blood draw will be performed at Day 42 (2 weeks after completing treatment). AEs and concomitant medication use will also be collected in any subject coming back for the Day 42 visit. Digital ECGs (12-lead) will be collected in triplicate at each time point over a period not to exceed 1 hour. During treatment, ECGs will be collected 4 hours after a dose (approximate Tmax).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Miltefosine | – | Drug: MiltefosineMiltefosine: target of 2.5 mg/kg/day for 28 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Persons with mucocutaneous leishmaniasis being treated with miltefosine
Key inclusion criteria (12 listed)
- Provide written informed consent
- Be available to complete study procedures
- Have a diagnosis of mucocutaneous leishmaniasis confirmed by microscopy of a stained smear of a lesion sample, by culture of a lesion sample, or by polymerase chain reaction (PCR) of a lesion sample or by Montenegro skin test and be willing to undergo treatment with miltefosine
- Be male or female and 18-55 years of age
- Have alanine aminotransferase (ALT), total bilirubin, and creatinine < 1.5 x upper upper limit of normal (ULN)
Key exclusion criteria (4 listed)
- Be a female who is breast feeding
- Be a female who is pregnant
- In the past 28 days prior to the start of miltefosine treatment have received any drug or other treatment that is known to significantly affect the QTc interval
- Have positive serology for Chagas disease
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: Impavido | Drug | Miltefosine |
Primary outcome
mean value of corrected QT interval
Time frame: up to 2 weeks after end of treatment
QTcF
1 secondary outcome
number of patients with adverse events
Time frame: up to 2 months after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 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.
Jaime Soto, MD principal investigator
Fundacion Nacional de Dermatologia
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 Mucocutaneous Leishmaniasis, run by Knight Therapeutics (USA) Inc at 1 site in Bolivia.
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 12 inclusion and 4 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: finished, as of the sponsor's last update on 4 Sep 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 Bolivia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mean value of corrected QT interval (time frame: up to 2 weeks after end of treatment). 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 4 Sep 2020.