Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis

• Status: Completed
• Trial end date: 2018-03-06
• Target enrollment: 0
• Participant gender: All

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Knight Therapeutics (USA) Inc
• Treatments: Miltefosine

Criteria

Inclusion Criteria:

1. Provide written informed consent

2. Be available to complete study procedures

3. 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

4. Be male or female and 18-55 years of age

5. Have alanine aminotransferase (ALT), total bilirubin, and creatinine < 1.5 x upper upper limit of normal (ULN)

6. Have white blood cell (WBC) count, hemoglobin, and platelet count within 15% of within normal limits (WNL)

7. Be without clinically significant non-cardiac medical disorder

8. 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)

9. 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)

10. Have no family history of sudden cardiac death before age 40

11. Have no personal history ischemic heart disease, congestive heart failure, palpitations, dizziness, syncope, cardiac arrhythmias

12. 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

Exclusion Criteria:

1. Be a female who is breast feeding

2. Be a female who is pregnant

3. 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

4. Have positive serology for Chagas disease