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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

Sponsor: 60 Degrees Pharmaceuticals LLC · Participants: 40 · Started: Nov 18, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06656351

Locations in the U.S.

New YorkIcahn 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.