B-FREE Chronic Babesiosis Study

NCT06656351 | Recruiting Phase 2 FDA Drug

• 1 other identifier: TQ-BA-2024-3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Babesiosis

Keywords

Chronic Babesiosis

Outcome Measures

Primary Outcomes (1)

• Change in General Fatigue

  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.

  From enrollment until Day 90 of treatment.

Secondary Outcomes (3)

• Babesia nucleic acid test (NAT)

  From baseline until Day 90 of treatment.

• Babesia nucleic acid test (NAT)

  From baseline until Day 90 of treatment

• Babesia nucleic acid test (NAT) and RT PCR

  From baseline, Days 30, 60, 90, 120, and 180

Study Arms (1)

Tafenoquine

EXPERIMENTAL

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.

Drug: Tafenoquine 100mg

Interventions

Tafenoquine 100mg DRUG

Tafenoquine

Tafenoquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 60 Degrees Pharmaceuticals LLC: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Interventions

tafenoquine

Central Study Contacts

Core Research

CONTACT

212-241-7658; CoreResearch@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: November 18, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)