2023-509737-39-00招募中3 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).
Octapharma Pharmazeutika Produktionsgesellschaft mbH41 个研究点 分布在 7 个国家目标入组 182 人开始时间: 2024年2月26日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 182
- 试验地点
- 41
- 主要终点
- Since the study objective is to show the benefit of Panzyga administration as primary infection prophylaxis, the primary endpoint is not the major infection rate but occurrence of at least one major infection in CLL patients with or without primary infection prophylaxis with Panzyga. Please refer to the Protocol for more information on the Primary endpoint.
研究概览
简要总结
The primary objective of this study is to demonstrate the benefit of Panzyga administration compared with placebo as primary infection prophylaxis in CLL patients with secondary immunodeficiency (SID) undergoing CLL antineoplastic therapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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.
- •Hypogammaglobulinemia (IgG levels <5 g/L) as confirmed by the Central Laboratory.
- •≥18 years of age.
- •Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted.
排除标准
- •IgG treatment within 3 months prior to Screening.
- •Severe liver disease, with signs of ascites and/or hepatic encephalopathy.
- •Severe kidney disease (as defined by estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m 2).
- •Body weight >140 kg.
- •Eastern Cooperative Oncology Group (ECOG) performance score of >2 (Appendix1).
- •Pregnant and lactating women.
- •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.
- •Planned or ongoing immunosuppressive treatment (other than for CLL or corticosteroids) or other forbidden medication during the entire study duration after study enrollment.
- •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.
- •Known IgA deficiency with antibodies to IgA (as part of the patient´s medical history).
- •Known blood hyperviscosity, or other hypercoagulable states.
- •Female patients of childbearing potential unwilling to use a protocol-required method of contraception (as per protocol section 7.3.9 b) from the Screening Visit throughout the study treatment period and for 30 days following the last dose of study drug.
- •Patients unable or unwilling to understand or comply with the study protocol.
- •Human immunodeficiency virus (HIV) infection at Screening (defined for the study as positive HIV antibody test).
- •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.
- •Uncontrolled hepatitis C infection at Screening (defined for the study as positive hepatitis virus C (HCV) polymerase chain reaction (PCR)).
- •Antibiotic prophylaxis and/or treatment within 7 days prior to Baseline (with the exception of trimethoprim-sulfamethoxazole (TMP/SMX), diaminodiphenyl sulfone [dapsone] and pentamidine inhalation).
- •Current major infection or >1 major infection in the previous 6 months before Baseline.
- •History of anaphylaxis or severe systemic response to immunoglobulin, blood or plasma-derived products or any Panzyga component.
- •History of a non-CLL malignancy or other medical condition with life-expectancy of less than two years.
结局指标
主要结局
Since the study objective is to show the benefit of Panzyga administration as primary infection prophylaxis, the primary endpoint is not the major infection rate but occurrence of at least one major infection in CLL patients with or without primary infection prophylaxis with Panzyga. Please refer to the Protocol for more information on the Primary endpoint.
Since the study objective is to show the benefit of Panzyga administration as primary infection prophylaxis, the primary endpoint is not the major infection rate but occurrence of at least one major infection in CLL patients with or without primary infection prophylaxis with Panzyga. Please refer to the Protocol for more information on the Primary endpoint.
次要结局
- 3. Duration of prophylaxis with anti-infectives (antibacterials and antivirals).
- 1. Overall infection rate: infection rate for all infections.
- 2. Frequency of prophylaxis with anti-infectives (antibacterials and antivirals).
研究者
Global Clinical Project Manager
Scientific
Octapharma Pharmazeutika Produktionsgesellschaft mbH
研究点 (41)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of a Long Acting Anti-Psychotic Versus Placebo in Patients With SchizophreniaSchizophreniaNCT00101634Johnson & Johnson Pharmaceutical Research & Development, L.L.C.518
Unknown
2 期
Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial VaginosisHUDC_VTHaudongchunBacterial VaginosisNCT03357666Haudongchun Co., Ltd.150
已完成
2 期
Phase II Study of STA-2 in Patients With Chronic Stable AnginaChronic Stable AnginaNCT01484912Sinphar Pharmaceutical Co., Ltd79
已完成
3 期
A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)Rheumatoid ArthritisNCT02265705Eli Lilly and Company290
已完成
4 期
Statin Therapy in Heart Failure: Potential Mechanisms of BenefitHeart Failure, CongestiveNCT00233480University of California, Los Angeles27