CTIS2022-502193-16-00招募中1 期
A Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® plus Standard Medical Treatment Compared to Placebo plus Standard Medical Treatment to Prevent Infections in Patients with Hypogammaglobulinemia and Recurrent or Severe Infections Associated with B-cell Chronic Lymphocytic Leukemia - GC2202
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 365
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 65+（—）
- 性别
- All
入选标准
- •Male or Female subjects =18 years of age at Screening Visit, Subjects with documented and confirmed diagnosis of B-cell CLL according to International Workshop on CLL (iwCLL) criteria, Subjects with hypogammaglobulinemia with IgG levels <4 g/L, Subjects with RAI staging of intermediate (1 and 2) or high (3 and 4) as documented in the subject’s medical history, Subjects with documented history of at least one severe bacterial infection or recurrent bacterial infections (i.e. = 3 infections) within 12 months before the Screening Visit. Severe bacterial infections = Grade 3 (as defined by Common Terminology Criteria for Adverse Events [CTCAE] Grades), Subjects have signed an informed consent form (ICF) prior to initiation of any study procedures
排除标准
- •Subjects with documented history of hematopoietic stem cell transplant, Subjects have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement), Females of childbearing potential who are pregnant, have a positive pregnancy test at Screening Visit (serum human chorionic gonadotropin-based assay), are breastfeeding, or unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence*) throughout the study. Note: *True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.), Subjects with severe known kidney disease (as defined by estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) as determined by the Principal Investigator, Subjects that have liver enzyme levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST], gammaglutamyl transferase [GGT], or lactate dehydrogenase [LDH]) greater than 3 times the upper limit of normal (ULN) at the Screening Visit as defined by the testing laboratory, Subjects who have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (e.g., myocardial infarction, cerebrovascular accident, or transient ischemic attack) or deep venous thrombosis, Subjects who are currently receiving anti-coagulation therapy which would make SC administration inadvisable (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [e.g., dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa], and parenteral anticoagulants [e.g., fondaparinux]), Subjects who currently have a known hyperviscosity syndrome or hypercoagulable states, Subjects who have a known previous infection with or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection, Subjects with non-controlled arterial hypertension (systolic blood pressure [SBP] >140 mmHg and/or diastolic blood pressure [DBP] >90 mmHg), and a heart rate (HR) >100 bpm, Subjects have known substance or prescription drug abuse within 12 months before the Screening Visit, Subjects currently receiving immunoglobulin replacement therapy (IgRT) or have received IgG replacement treatment (i.e., prior immune globulin replacement therapy) within 6 months before the Screening Visit, Subjects have participated in another clinical trial within 30 days prior to Screening Visit (observational studies without investigative treatments [non-interventional] are permitted), Subjects/caregivers are unwilling to comply with any aspect of the protocol for the duration of the study, In the opinion of the investigator, subjects may have compliance problems with the protocol and the procedures of the protocol, Subjects with active infections or receiving therapeutic or prophylactic antibiotic treatmen
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