NL-OMON55174已完成不适用
A multicenter, Phase 1b, open label, nonrandomized, single dose study evaluating the safety, tolerability and activity of BIVV020 in adults with cold agglutinin disease - PDY16370
适应症
试验速览
- 阶段
- 不适用
- 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/or female patients, * 18 years of age with cold agglutinin disease
- •as defined by:
- •a) Chronic hemolysis per Investigator*s judgement,
- •b) Polyspecific direct antiglobulin test (DAT) positive,
- •c) Monospecific DAT strongly positive for C3d,
- •d) Cold agglutinin (CAg) titer * 64 at 4°C; and,
- •e) IgG DAT *1+.
- •- A hemoglobin level *11 mg/dL.
- •- A total bilirubin level above the normal reference range that is thought to
- •be due to hemolysis.
- •- Documented vaccinations against encapsulated bacterial pathogens (Neisseria
- •meningitidis,
- •including serogroup B meningococcus and Streptococcus pneumoniae) within five
- •screening or willing to complete protocol specified vaccinations.
- •- Having given written informed consent prior to undertaking any study-related
排除标准
- •- Cold agglutinin syndrome secondary to infection, rheumatologic disease, or
- •known high grade
- •hematologic malignancy, or known solid organ tumor.
- •- Clinically relevant infection of any kind within one month preceding
- •- Treatment with anti-CD20 monotherapy within three months or anti CD20
- •combination therapies
- •within six months prior to screening.
- •- Concurrent treatment with systemic immunosuppressive agents targeting B- or
- •T-cell function
- •and/or cytotoxic agents within 3 months prior to screening. Concurrent
- •treatment with other
- •systemic immunosuppressants within 5.5 half-lives of the drug prior to
- •- Any specific complement system inhibitor within three months prior to
- •- Concurrent treatment with systemic corticosteroids other than a stable daily
- •dose equivalent to
- •*10 mg/day prednisone within three months prior to screening.
- •- If female, pregnant or lactating.
研究者
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