EUCTR2019-004375-40-IT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
适应症
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 trimethoprimsulfamethoxazole
- •[TMP/SMX] diaminodiphenyl sulfone [dapsone] and pentamidine inhalation).
- •Current major infection or >1 major infection in the previous 6
- •before Baseline.
- •History of anaphylaxis or severe systemic response to
- •immunoglobulin,
- •blood or plasma-derived products or any Panzyga
- •History of a non-CLL malignancy with life-expectancy of less than two
- •Severe liver disease, with signs of ascites and/or hepatic
- •encephalopathy.
- •Severe kidney disease (as defined by estimated glomerular filtration
- •[eGFR] <30 mL/min/1.73 m2).
- •Body weight >140 kg.
- •Eastern Cooperative Oncology Group (ECOG) performance score of >2
- •Female patients of childbearing potential unwilling to use a protocolrequired
- •method of contraception from the Screening Visit throughout
- •study treatment period and for 30 days following the last dose of
- •Human immunodeficiency virus (HIV) infection at Screening (defined
- •the study as positive HIV antibody test).
- •Patients found to be chronic carriers of hepatitis B virus (HBV),
- •by positivesurface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and/or low HBV
- •who will not receive targeted antiviral therapy while undergoing
- •therapy, and patients with active HBV, defined as high HBV titers.
- •Uncontrolled hepatitis C infection at Screening (defined for the study
- •positive hepatitis virus C [HCV] polymerase chain reaction [PCR]).
- •Pregnant and lactating women.
- •Subjects with a history of thromboembolic events (TEE) such as deep
- •thrombosis, pulmonary embolism, myocardial infarction, ischemic
- •transient ischemic attack, peripheral artery disease (Fontaine IV)
- •6 months before Baseline.
- •Planned or ongoing immunosuppressive treatment (other than for
- •or corticosteroids) or other forbidden medication during the entire
- •duration after study enrollment.
- •Participation in another interventional clinical trial that is either
- •or involves an investigational (not approved) product within 3
- •before Baseline or during the course of the clinical study.
- •Participation
- •in observational clinical trials or open-label trials involving
- •approved product may be permitted after consultation with the
- •Known IgA deficiency with antibodies to IgA.
- •Known blood hyperviscosity, or other hypercoagulable states.
- •Patients unable or unwilling to understand or comply with the study
研究者
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