Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
- 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
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. Change in General Fatigue MFI subscale score at Day 90 compared with baseline.
- Secondary Outcome Measures
Name Time Method