RecruitingPhase 2NCT06656351
B-FREE Chronic Babesiosis Study
B-FREE Chronic Babesiosis Study: A Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients With Severe Fatigue
Sponsor
60 Degrees Pharmaceuticals LLC
Enrollment
40 participants
Start Date
Nov 18, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria14
- 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
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Interventions
DRUGTafenoquine 100mg
Tafenoquine
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06656351