Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT06656351
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2024-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
B-FREE Chronic Babesiosis Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C055852', 'term': 'tafenoquine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in General Fatigue', 'timeFrame': 'From enrollment until Day 90 of treatment.', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Babesia nucleic acid test (NAT)', 'timeFrame': 'From baseline until Day 90 of treatment.', 'description': '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'}, {'measure': 'Babesia nucleic acid test (NAT)', 'timeFrame': 'From baseline until Day 90 of treatment', 'description': 'Proportion of patients with a reactive NAT test at baseline who had a non-reactive NAT test at Day 90'}, {'measure': 'Babesia nucleic acid test (NAT) and RT PCR', 'timeFrame': 'From baseline, Days 30, 60, 90, 120, and 180', 'description': '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)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Babesiosis'], 'conditions': ['Chronic Babesiosis']}, 'descriptionModule': {'briefSummary': 'Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged ≥ 18 years\n* Severe disabling fatigue\n* Have at least one common symptom of babesiosis\n* Have laboratory evidence of exposure to babesia in the last 12 months\n* Able and willing to give written informed consent\n* Able and willing to perform all study assessments\n* If female negative urine pregnancy test and\n* If female agree to use an acceptable method of birth control\n\nExclusion Criteria:\n\n* Glucose-6-phosphate-dehydrogenase (G6PD) deficiency\n* Breastfeeding\n* Unmanaged Psychotic disorder\n* Known hypersensitivity reaction to tafenoquine or other 8-aminoquinolines\n* Current or planned treatment with quinine\n* Uncontrolled cardiopulmonary or endocrine disorders\n* Taking OCT2/MATE substrates without appropriate medical oversight\n* Medical history of chronic, active viral diseases including HIV/AIDS, hepatitis B, and hepatitis C\n* Have a risk factors for relapsing babesiosis\n* Anorexia\n* Any concomitant significant illness unrelated to babesiosis\n* The patient is unable to tolerate medication by the oral route\n* The patient has previously taken tafenoquine\n* Hemoglobin at baseline is ≤ 8 g/dL'}, 'identificationModule': {'nctId': 'NCT06656351', 'acronym': 'TQ-BA-2024-3', 'briefTitle': 'B-FREE Chronic Babesiosis Study', 'organization': {'class': 'INDUSTRY', 'fullName': '60 Degrees Pharmaceuticals LLC'}, 'officialTitle': 'B-FREE Chronic Babesiosis Study: A Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients With Severe Fatigue', 'orgStudyIdInfo': {'id': 'TQ-BA-2024-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tafenoquine', 'description': '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.', 'interventionNames': ['Drug: Tafenoquine 100mg']}], 'interventions': [{'name': 'Tafenoquine 100mg', 'type': 'DRUG', 'description': 'Tafenoquine', 'armGroupLabels': ['Tafenoquine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Putrino', 'role': 'CONTACT'}, {'name': 'David Putrino, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Core Research', 'role': 'CONTACT', 'email': 'CoreResearch@mountsinai.org', 'phone': '212-241-7658'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '60 Degrees Pharmaceuticals LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}