Chronic BabesiosisPhase 2TQ-BA-2024-3NCT06656351
B-FREE Chronic Babesiosis Study
A Phase 2 study testing Tafenoquine 100mg in people with Chronic Babesiosis, run by 60 Degrees Pharmaceuticals LLC at 1 site in United States.
Trial summary
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Babesiosis
- What is being tested?
- Tafenoquine 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2025to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
David Putrino
David Putrino, PhD
About this study
Official title: 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
- Conditions
- Chronic Babesiosis
- Being tested
- Tafenoquine 100mg
- Keywords
- Chronic Babesiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tafenoquine 100mgDrug
Tafenoquine
| Study group | Role | What they receive |
|---|---|---|
| Tafenoquine | Experimental | 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. Receives: Drug: Tafenoquine 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in General Fatigue
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.
Measured: From enrollment until Day 90 of treatment.
Secondary outcomes (3)
Babesia nucleic acid test (NAT)
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
Measured: From baseline until Day 90 of treatment.
Babesia nucleic acid test (NAT)
Proportion of patients with a reactive NAT test at baseline who had a non-reactive NAT test at Day 90
Measured: From baseline until Day 90 of treatment
Babesia nucleic acid test (NAT) and RT PCR
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)
Measured: From baseline, Days 30, 60, 90, 120, and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start18 Nov 2025
- Primary completionFeb 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic BabesiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 60 Degrees Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656351
- Sponsor's protocol ID
- TQ-BA-2024-3
- Acronym
- TQ-BA-2024-3
- Status last verified
- Nov 2025
- First submitted
- 22 Oct 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-FREE Chronic Babesiosis Study: A Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients With Severe Fatigue
- ClinicalTrials.gov ID
- NCT06656351
- Acronym / sponsor ID
- TQ-BA-2024-3 / TQ-BA-2024-3
- Conditions
- Chronic Babesiosis
- Keywords
- Chronic Babesiosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- 60 Degrees Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tafenoquine | Experimental | Drug: Tafenoquine 100mgTafenoquine (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tafenoquine 100mgTafenoquine | Drug | Tafenoquine |
Primary outcome
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.
3 secondary outcomes
Babesia nucleic acid test (NAT)
Time frame: From baseline until Day 90 of treatment.
Babesia nucleic acid test (NAT)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tafenoquine 100mg in people with Chronic Babesiosis, run by 60 Degrees Pharmaceuticals LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Core Research (212-241-7658, CoreResearch@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in General Fatigue (time frame: From enrollment until Day 90 of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.