Home › NCT06656351
B-FREE Chronic Babesiosis Study
RecruitingPhase 2
B-FREE Chronic Babesiosis Study: A Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients With Severe Fatigue
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
What is being tested
- Tafenoquine 100mg (drug)
Sponsor: 60 Degrees Pharmaceuticals LLC · Participants: 40 · Started: Nov 18, 2025
Contact the study team
- Core Research · Phone: 212-241-7658
Official record on ClinicalTrials.gov — NCT06656351
Locations in the U.S.
| New York | Icahn School of Medicine at Mount Sinai, New York |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.