B-FREE Chronic Babesiosis Study: A Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients With Severe Fatigue
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female, aged ≥ 18 years
• Severe disabling fatigue
• Have at least one common symptom of babesiosis
• Have laboratory evidence of exposure to babesia in the last 12 months
• Able and willing to give written informed consent
• Able and willing to perform all study assessments
• If female negative urine pregnancy test and
• If female agree to use an acceptable method of birth control
Locations
United States
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Core Research
CoreResearch@mountsinai.org
212-241-7658
Time Frame
Start Date: 2025-11-18
Estimated Completion Date: 2027-09
Participants
Target number of participants: 40
Treatments
Experimental: Tafenoquine
Tafenoquine (2 x 100 mg tablets) will be self-administered orally with food on Days 1, 2, 3, 4, then weekly thereafter for a total 12-week treatment period. Weekly treatment will start on Day 11 and end on Day 89.
Related Therapeutic Areas
Sponsors
Leads: 60 Degrees Pharmaceuticals LLC