NL-OMON52011已完成2 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) - PDY16894
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 × 10^9/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
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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