Skip to content
Bored Studies
RecruitingPhase 2

B-FREE Chronic Babesiosis Study

60 Degrees Pharmaceuticals LLC · NCT06656351

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
40
US sites recruiting
1
Study start
November 18, 2025
Record last updated
November 21, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue

Being studied: Tafenoquine 100mg

Conditions: Chronic Babesiosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Icahn School of Medicine at Mount Sinai

    New York, NY 10029

    Site contact: David Putrino

Study contacts (from the official record)

  • Core Research · 212-241-7658 · CoreResearch@mountsinai.org
B-FREE Chronic Babesiosis Study (NCT06656351) | Bored Studies