EUCTR2020-004162-18-DE进行中（未招募）1 期
A multicenter, Phase 2a, open-label, non-randomized study evaluating the efficacy, safety, and tolerability of BIVV020 in adults with persistent/chronic immune thrombocytopenia (ITP)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female participants =18 years of age at the time of signing the
- •informed consent
- •- Confirmed diagnosis of primary ITP; for participants who previously
- •received sutimlimab in study TDR16218 (NCT03275454), a response to
- •sutimlimab must have been obtained, as defined by platelet count =30 ×
- •10^9/L on 2 visits at least 7 days apart
- •- For participants who have not previously received sutimlimab:
- •persistent/chronic ITP (ITP lasting for =6 months) and all the following conditions:
- •a) Platelet count =30 × 10^9/L on 2 occasions at least 5 days apart during
- •the Screening Period;
- •b) Lack of an adequate platelet count response (as defined by
- •maintenance of sustained platelet count =30 × 109/L in the absence of bleeding) to at least 2 ITP treatments, 1 of which was a thrombopoietin receptor agonist. Other ITP treatments include: IVIg, anti-D immunoglobulin, corticosteroids, splenectomy, rituximab, cyclophosphamide, azathioprine, danazol, cyclosporin A, mycophenolate mofetil, or fostamatinib.
- •c) If receiving weekly thrombopoietin receptor agonist dosing, the last
- •dose must have been administered =7 days before the first dose of
- •BIVV020. If receiving daily thrombopoietin receptor agonist dosing, the
- •last dose must have been administered =24 hours before the first dose of
- •d) If applicable, concurrent administration of ITP medications (eg.
- •corticosteroids, IVIg, azathioprine, danazol, cyclosporin A, mycophenolate
- •mofetil, or thrombopoietin receptor agonists) is acceptable provided the
- •patient has been on a stable dose for at least 1 month.
- •e) If previously dosed with rituximab, the last dose of rituximab must have
- •been administered at least 12 weeks before the first dose of BIVV020
- •- Documented vaccinations against encapsulated bacterial pathogens
- •(Neisseria meningitidis, including serogroup B where available,
- •Haemophilus influenzae, and Streptococcus pneumoniae) within 5 years
- •of enrollment
- •- Contraceptive use for women of childbearing potential and men who are
- •sexually active with a female partner of childbearing potential
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Clinically significant medical history or ongoing chronic illness that
- •would jeopardize the safety of the participant or compromise the quality of
- •the data derived from his/her participation in the study
- •- Clinical diagnosis of SLE
- •- Clinically relevant infection within the month prior to enrollment
- •- History of venous or arterial thrombosis within the year prior to
- •- Secondary ITP from any cause including lymphoma, chronic
- •lymphocytic leukemia, and drug-induced thrombocytopenia
- •- Positive hepatitis B surface antigen (HBsAg) or active HCV
- •- HIV infection
- •- Pregnant or lactating women
- •- Hemoglobin level <10 g/dL
研究者
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