NL-OMON54300招募中不适用
An open label, long term, safety and tolerability study of patients with cold agglutinin disease previously treated with SAR445088 or never treated with SAR445088 - LTS16637
Sanofi BV0 个研究点目标入组 2 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 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 adult patients >=18 years of age with CAD who were previously
- •treated with SAR445088 and met the below criteria for entry into Part 1:
- •- met the eligibility criteria of a previous study evaluating SAR445088;
- •- successfully enrolled and completed dosing in a previous study evaluating
- •- successfully completed end of study procedures in a previous study
- •evaluating SAR445088; and
- •- per Investigator judgement, had a favorable benefit to risk profile after
- •receiving SAR445088.
- •were never treated with SAR445088 before entering Part 2, and met the below
- •criteria to establish CAD diagnosis:
- •chronic hemolysis;
- •polyspecific direct antiglobulin test (DAT) positive status;
- •monospecific DAT strongly positive for C3d;
- •cold agglutinin [CAg] titer >=64 at 4°C;
- •IgG DAT <=1+;
- •hemoglobin level <=10 g/dL;
- •elevated bilirubin not attributable to liver disease;
- •* Documented vaccinations against encapsulated bacterial pathogens given within
- •five years of
- •enrollment and at least 14 days prior to dosing
- •* Contraception (with double contraception methods) for male and female
- •participants;
- •not pregnant or breastfeeding for female participants; no sperm donation for
- •participants.
- •* 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 within one month of enrollment.
- •* Clinical diagnosis of systemic lupus erythematosus (SLE).
- •* 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 other than SAR445088 (eg,
- •eculizumab) within three months prior to screening.
- •* Concurrent treatment with systemic corticosteroids other than a stable daily
- •dose equivalent to <=10
- •mg/day prednisone within three months prior to screening.
- •* History of hypersensitivity to SAR445088 or any of its components.
研究者
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