NCT06656351PHASE2Recruiting
B-FREE Chronic Babesiosis Study
60 Degrees Pharmaceuticals LLC
Start Date
11/18/2025
Completion Date
9/1/2027
Summary
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 ≤ 8 g/dL
Interventions
DRUG
Tafenoquine 100mg
Conditions
Chronic Babesiosis
Locations
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States