B-FREE Chronic Babesiosis Study (TQ-BA-2024-3)

60 Degrees Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Chronic Babesiosis

Treatments: Drug: Tafenoquine 100mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06656351

TQ-BA-2024-3

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Tafenoquine

Experimental group

Description:

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.

Treatment:

Drug: Tafenoquine 100mg