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

November 18, 2025 updated by: 60 Degrees Pharmaceuticals LLC

B-FREE Chronic Babesiosis Study: A Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients With Severe Fatigue

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
          • David Putrino
        • Principal Investigator:
          • David Putrino, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tafenoquine
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.
Drug: Tafenoquine 100mg
Tafenoquine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment until Day 90 of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Babesia nucleic acid test (NAT)
Time Frame: From baseline until Day 90 of treatment.
Percentage of patients achieving molecular cure at or earlier than Day 90 who tested positive on the Babesia NAT at baseline, with molecular cure defined as the observance of a negative Babesia NAT test on or before Day 90
From baseline until Day 90 of treatment.
Babesia nucleic acid test (NAT)
Time Frame: From baseline until Day 90 of treatment
Proportion of patients with a reactive NAT test at baseline who had a non-reactive NAT test at Day 90
From baseline until Day 90 of treatment
Babesia nucleic acid test (NAT) and RT PCR
Time Frame: From baseline, Days 30, 60, 90, 120, and 180
Number and percentage of patients with a negative Babesia screen on Days 30, 60, 90, 120, and 180 who tested positive at baseline, as assessed individually for each molecular diagnostic test (rtPCR, dPCR, and NAT)
From baseline, Days 30, 60, 90, 120, and 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

60 Degrees Pharmaceuticals LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQ-BA-2024-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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