Prospective, Multi-center, Open-label Study Measuring Safety and Treatment Satisfaction in Adult Subjects With Chronic Immune Thrombocytopenia (ITP) After Switching to Avatrombopag From Eltrombopag or Romiplostim
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sobi, Inc.
- 入组人数
- 60
- 试验地点
- 20
- 主要终点
- Safety and Tolerability (Adverse Events)
研究概览
简要总结
Evaluate the safety and tolerability of avatrombopag given for 90 days after stopping treatment with eltrombopag or romiplostim.
详细描述
This Phase 4, prospective, multi-center, open-label study will evaluate safety, platelet count, and subject reported medication satisfaction in adult subjects with chronic ITP after switching to avatrombopag from eltrombopag or romiplostim. At least 100 subjects will be enrolled, 50 (±10) who have received eltrombopag and 50 (±10) who have received romiplostim for at least 90 days prior to study entry.
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
- •Subject has been undergoing treatment for primary ITP with eltrombopag or romiplostim for at least 90 days prior to the Screening Visit/Visit
- •Subject has had a previous response (at any time) to either eltrombopag or romiplostim, defined as at least 2 platelet counts ≥50×10⁹/L. Subject is willing and able to comply with all aspects of the protocol, including completing the self-administered Treatment Satisfaction Medication Questionnaire (TSQM).
排除标准
- •Subject is currently receiving chemotherapy or radiation for any form of cancer.
- •Subject with conditions that are likely to prevent them from accurately and reliably completing study assessments, including evidence of moderate to severe dementia, and/or severe and progressive medical illness, as determined by the Investigator.
- •Any previous avatrombopag use.
- •Previous participation in this study; a subject may not re-enroll after prior discontinuation or completion.
- •Enrollment in another clinical study with any investigational drug or device within 30 days of Baseline (or 5 half-lives, whichever is longer); however, participation in observational studies within the previous 30 days is permitted.
研究组 & 干预措施
Avatrombopag
Avatrombopag 20 mg oral tablet formulation for 90 days
干预措施: Avatrombopag Oral Tablet (Drug)
结局指标
主要结局
Safety and Tolerability (Adverse Events)
时间窗: Screening through Day 90 or End of Study
Safety and Tolerability of Avatrombopag given for 90 days after stopping eltrombopag or romiplostim The incidence and severity of adverse events (AEs), serious adverse events (SAE) and adverse events of special interest (AESIs) will be summarized for all enrolled subjects using counts and percentages. Treatment-emergent AEs and SAEs will be summarized overall, by system organ class, and by preferred term. AESIs will be summarized by event type (thromboembolic events and bleeding events). In addition, treatment-emergent AEs will be summarized by severity and by relationship to study drug. Bleeding events reported during the study will be summarized by WHO grade.
次要结局
- Change From Baseline TSQM Convenience Domain Score(Day 90)
- Change From Baseline TSQM Side Effects Domain Score(Day 90)
- Change From Baseline TSQM Effectiveness Domain Score(Day 90)
- Change From Baseline TSQM Global Satisfaction Domain Score(Day 90)
- Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L(Day 90)