Overview

Determining a Tolerable Dose of Primaquine in G6PD-deficient Persons Without Malaria in Mali

Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the highest tolerable dose of primaquine within 0.75 mg/kg. A tolerable dose is defined as one in which: - Two or fewer participants (< 30%) experience hemolysis; - No participant experiences a drug-related serious adverse event; and - No participant requires a blood transfusion.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
Bill and Melinda Gates Foundation
Malaria Research and Training Center, Bamako, Mali
Radboud University
University of Mississippi Medical Center
Treatments:
Primaquine