B-FREE Chronic Babesiosis Study

Part of paid clinical trials in New York, New York.

Sponsor: 60 Degrees Pharmaceuticals LLC
Study ID: NCT06656351
Phase: PHASE2
Status: Recruiting

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Conditions

Chronic Babesiosis

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Tafenoquine 100mg — DRUG
Tafenoquine

Study Details

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

Key Dates

Start date: Nov 18, 2025
Status verified: Nov 2025
Primary completion: Feb 28, 2027
Completion: Sep 30, 2027

Study Design

Enrollment: 40 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Tafenoquine
Tafenoquine (2 x 100 mg tablets) will be self-administered orally with food on Days 1, 2, 3, 4, then weekly thereafter for a total 12-week treatment period. Weekly treatment will start on Day 11 and end on Day 89.

Primary Outcome Measure

Change in General Fatigue [ Time Frame: From enrollment until Day 90 of treatment. ]

Central Contacts

Core Research
212-241-7658
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Icahn School of Medicine at Mount Sinai	New York	New York	10029	David Putrino David Putrino, PhD (PRINCIPAL_INVESTIGATOR)

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Icahn School of Medicine at Mount Sinai· New York, NY