EUCTR2019-004375-40-HU进行中（未招募）1 期
Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia (PRO-SID” study) - PRO-SID
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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
- •1. Treatment-naïve or relapsed/refractory CLL patients undergoing CLL antineoplastic treatment. Diagnosis of B-cell CLL established according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and documented within medical records.
- •2. Hypogammaglobulinemia (IgG levels <5 g/L) as confirmed by the Central Laboratory.
- •3. =18 years of age.
- •4. Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted.
- •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 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 225
排除标准
- •1. IgG treatment within 3 months prior to Screening.
- •2. Antibiotic prophylaxis and/or treatment within 7 days prior to current CLL treatment start (with the exception of trimethoprim-sulfamethoxazole [TMP/SMX], diaminodiphenyl sulfone [dapsone] and pentamidine inhalation).
- •3. Current major infection or >1 major infection in the previous 6 months before Baseline.
- •4. History of anaphylaxis or severe systemic response to immunoglobulin, blood or plasma-derived products or any Panzyga component.
- •5. History of a non-CLL malignancy with life-expectancy of less than two years.
- •6. Severe liver disease, with signs of ascites and/or hepatic encephalopathy.
- •7. Severe kidney disease (as defined by estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2).
- •8. Body weight >140 kg.
- •9. Eastern Cooperative Oncology Group (ECOG) performance score of >2 (Appendix 1).
- •10. Female patients of childbearing potential unwilling to use a protocol-required method of contraception from the Screening Visit throughout the study treatment period and for 30 days following the last dose of study drug.
- •11. Human immunodeficiency virus (HIV) infection at Screening (defined for the study as positive HIV antibody test).
- •12. Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and/or low HBV titers, who will not receive targeted antiviral therapy while undergoing CLL therapy, and patients with active HBV, defined as high HBV titers.
- •13. Uncontrolled hepatitis C infection at Screening (defined for the study as positive hepatitis virus C [HCV] polymerase chain reaction [PCR]).
- •14. Pregnant and lactating women.
- •15. Subjects with a history of thromboembolic events (TEE) such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease (Fontaine IV) within 6 months before Baseline.
- •16. Planned or ongoing immunosuppressive treatment (other than for CLL or corticosteroids) or other forbidden medication during the entire study duration after study enrollment.
- •17. Participation in another interventional clinical trial that is either blinded or involves an investigational (not approved) product within 3 months before Baseline or during the course of the clinical study. Participation in observational clinical trials or open-label trials involving an approved product may be permitted after consultation with the medical monitor.
- •18. Known IgA deficiency with antibodies to IgA (as part of the patient´s medical history).
- •19. Known blood hyperviscosity, or other hypercoagulable states.
- •20. Patients unable or unwilling to understand or comply with the study protocol.
研究者
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