NCT06656351 · 60 Degrees Pharmaceuticals LLC
B-FREE Chronic Babesiosis Study
(TQ-BA-2024-3)
What this study is about
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
View original scientific description
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
Interventions
DRUG
Tafenoquine 100mg
Tafenoquine
Primary outcome measures
Change in General Fatigue
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 21, 2025 · Source of record for eligibility and locations