Phase 2 Open Label Study of Tafenoquine

Phase 2

Not yet recruiting

• Conditions: Chronic Babesiosis
• Interventions: Drug: Tafenoquine 100mg

• Registration Number: NCT06656351
• Lead Sponsor: 60 Degrees Pharmaceuticals LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-22
• Study First Posted: 2024-10-24
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-22
• Last Update Posted: 2025-09-25
• Study Start: 2026-01-01
• Primary Completion: 2027-02
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Male or female, aged ≥ 18 years
• Has received a diagnosis of chronic babesiosis
• Severe disabling fatigue
• 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
• Any concomitant significant illness unrelated to babesiosis
• Any excluded concomitant medication
• Taking or intending to take quinine
• The patient is unable to tolerate medication by the oral route
• The patient has previously taken tafenoquine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tafenoquine	Tafenoquine 100mg	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 Measures

Name	Time	Method
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). The scale and instructions are provided in Appendix F. 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.