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Clinical Trials in the USA / NCT06656351
Recruiting Phase 2

B-FREE Chronic Babesiosis Study

NCT06656351 · tracked via the Priya Life Science USA tracker
Sponsor
60 Degrees Pharmaceuticals LLC
Phase
Phase 2
Started
2025-11-18
Last updated
2025-11-21

Condition(s) studied

Chronic Babesiosis

Investigational drug(s) / intervention(s)

Tafenoquine 100mg →

Tafenoquine 100mg: Tafenoquine

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in General Fatigue — From enrollment until Day 90 of treatment.
    The Multidimensional Fatigue Inventory (MFI) is a 20-item, patient-reported scale. designed to evaluate five dimensions of fatigue: general fatigue (items 1, 5, 12, 16), physical fatigue (items (items 2, 8, 14, 20), reduced motivation (items 3, 6, 10, 17), reduced activity (items 4, 9, 15, 18), and mental fatigue (items 7, 11, 13, 19) (Smets-1995). Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). This scale has been used to assess treatment outcomes in patients with chronic fatigue syndrome, women with fibromyalgia, Parkinson's disease, patients undergoing anti-cancer treatment, and the impact of fatigue on the quality of life in rheumatoid arthritis. Total scale score, and each of the 5 subscales scores will be calculated. MFI subscales are scored by summing four items, each has five possible responses giving a range of possible scores from 4 to 20.

Trial sites (1)

FacilityCityRegionStatus
Icahn School of Medicine at Mount Sinai New York New York Recruiting

More 60 Degrees Pharmaceuticals LLC trials in the USA

Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06656351 on ClinicalTrials.gov ↗ ← All trials in the USA