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NCT06656351 · ClinicalTrials.gov registry record · Phase 2
B-FREE Chronic Babesiosis Study
A Phase 2 study of Chronic Babesiosis, sponsored by 60 Degrees Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06656351: Recruiting Phase 2 study of Chronic Babesiosis, sponsored by 60 Degrees Pharmaceuticals.
NCT06656351 is a Phase 2 study of Chronic Babesiosis that is actively recruiting participants, run by 60 Degrees Pharmaceuticals. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06656351, a Phase 2 study of Chronic Babesiosis, is actively recruiting participants, sponsored by 60 Degrees Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Tafenoquine 100mg
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-11-18 |
| Est. Completion | 2027-09 |
| Phase | Phase 2 |
What NCT06656351 shows while recruiting
NCT06656351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Chronic Babesiosis appearing as the primary indexed condition, and to 1 intervention - of which Tafenoquine 100mg is the first listed.
NCT06656351 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06656351 about?
NCT06656351 is a clinical study titled "B-FREE Chronic Babesiosis Study". Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
What is the current status of trial NCT06656351?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-11-18. Estimated completion is 2027-09.
What conditions does trial NCT06656351 study?
This clinical trial studies the following conditions: Chronic Babesiosis.
What interventions are being tested in trial NCT06656351?
The interventions under investigation include: Tafenoquine 100mg (DRUG).
Who is sponsoring clinical trial NCT06656351?
This trial is sponsored by 60 Degrees Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06656351 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06656351's enrollment target sits among peer trials
40 1362nd of 2000 higher than 543 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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