Actively Recruiting
B-FREE Chronic Babesiosis Study
Led by 60 Degrees Pharmaceuticals LLC · Updated on 2025-11-21
40
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
CONDITIONS
Official Title
B-FREE Chronic Babesiosis Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 65 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
- If female agree to use an acceptable method of birth control
You will not qualify if you...
- Glucose-6-phosphate-dehydrogenase (G6PD) deficiency
- Breastfeeding
- Unmanaged Psychotic disorder
- Known hypersensitivity reaction to tafenoquine or other 8-aminoquinolines
- Current or planned treatment with quinine
- Uncontrolled cardiopulmonary or endocrine disorders
- Taking OCT2/MATE substrates without appropriate medical oversight
- Medical history of chronic, active viral diseases including HIV/AIDS, hepatitis B, and hepatitis C
- Have a risk factors for relapsing babesiosis
- Anorexia
- Any concomitant significant illness unrelated to babesiosis
- The patient is unable to tolerate medication by the oral route
- The patient has previously taken tafenoquine
- Hemoglobin at baseline is 64 8 g/dL
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
C
Core Research
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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