B-FREE Chronic Babesiosis Study: A Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients With Severe Fatigue
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in General Fatigue
研究概览
简要总结
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Tafenoquine 100mg (Drug)
结局指标
主要结局
Change in General Fatigue
时间窗: 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.
次要结局
- Babesia nucleic acid test (NAT)(From baseline until Day 90 of treatment)
- Babesia nucleic acid test (NAT) and RT PCR(From baseline, Days 30, 60, 90, 120, and 180)