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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

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Conditions

Chronic Babesiosis

Locations

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States