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Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafenoquine 100mg | Drug | Tafenoquine |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment until Day 90 of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline until Day 90 of treatment. |
| Babesia nucleic acid test (NAT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Core Research | Contact | 212-241-7658 | CoreResearch@mountsinai.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| C055852 | tafenoquine |
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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 | 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 |