NCT06987864已完成3 期
An Extension Clinical Study of BCD-148 (JSC BIOCAD) for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria Previously Treated in Clinical Study No. BCD-148-2/NOCTURN
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biocad
- 入组人数
- 24
- 试验地点
- 11
- 主要终点
- Change in lactate dehydrogenase (LDH) level from baseline estimated at Visit 1/Week 0 prior to drug administration
研究概览
简要总结
To study the long-term safety and efficacy of BCD-148 in patients with paroxysmal nocturnal hemoglobinuria (PNH), previously treated in clinical study (CS) BCD-148-2/NOCTURN
详细描述
The clinical study BCD-148-EXT was an extension of a multicenter, randomized, open-label, comparative study of the efficacy and safety of BCD-148 in PNH patients versus SOLIRIS® (BCD-148-2/NOCTURN).
Clinical study BCD-148-EXT is a Phase III study extension conducted after completion of BCD-148 900 mg therapy or SOLIRIS® 900 mg by subjects of clinical study BCD-148-2/NOCTURN.
In the BCD-148-EXT clinical study patients continued BCD-148 maintenance therapy for 105 weeks.
The BCD-148-EXT study consisted of two periods: screening period (not more than 7 days inclusive, i.e. 1 week from signing the patient information sheet and IC form) and the treatment period (Weeks 0 to 105 of the study, inclusive). As part of the treatment period, patients received intravenous infusions of the investigational drug BCD-148 in the maintenance therapy regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed IC form for participation in the study.
- •Indications for pathogenesis-based therapy of PNH with an anti-C5 monoclonal antibody (eculizumab).
- •Consent for revaccination against Neisseria meningitidis .
- •Negative pregnancy test for urine human chorionic gonadotropin (HCG) in women at enrollment in study BCD-148-EXT (the test was not performed in women who have been postmenopausal for at least 2 years, or in surgically sterile subjects) .
- •Willingness of patients and their sexual partners of childbearing potential to use reliable contraceptive measures from signing the IC form throughout the study and for 4 weeks after the last drug dosing in the clinical study. This requirement did not apply to patients who underwent surgical sterilization and women who have been postmenopausal for over 2 years. Reliable methods of contraception included the use by partners of one barrier method in combination with one of the following: spermicides, intrauterine device, oral contraceptives (for female partners of male subjects only, for female study participants - upon agreement with the Sponsor and with justification by the investigator) .
- •The ability of the patient to comply with the Protocol requirements, in the Investigator's opinion.
排除标准
- •Patient withdrawal from clinical study BCD-148-2/NOCTURN until its completion for any reason.
- •Pregnancy or breastfeeding, or planning of pregnancy by a female participant/planning conceiving a child by a male participant during the clinical study.
- •Any conditions that, in the investigator's opinion, could increase the patient's risk associated with participation in the study or could affect the assessment of the study results.
- •Hypersensitivity to BCD-148 components, murine proteins, and other components of the products according to the patient's history; hypersensitivity to any component of the meningococcal vaccine.
- •Known alcohol or drug addiction, or signs of alcohol/drug addiction, which, according to the investigator, were a contraindication for the treatment with the study drug or limited the treatment compliance.
研究组 & 干预措施
To study the long-term safety and efficacy of BCD-148 in patients with paroxysmal nocturnal hemoglob
Experimental
干预措施: eculizumab (Biological)
结局指标
主要结局
Change in lactate dehydrogenase (LDH) level from baseline estimated at Visit 1/Week 0 prior to drug administration
时间窗: 105 weeks
次要结局
- Proportion of patients with thrombotic complications(105 weeks)
- Change in the size of the PNH clone (change in the number of circulating red blood cells with the PNH phenotype) from baseline estimated at Visit 1/Week 0 prior to drug administration(105 weeks)
- Change in the mean Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Total Score from baseline as assessed at Visit 1/Week 0 prior to drug administration(105 weeks)
- Proportion of patients with adverse reactions (ARs), including those meeting the seriousness criteria(105 weeks)
- Proportion of patients with grade 3 or higher adverse reactions (ARs) according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0(105 weeks)
- Proportion of patients who prematurely withdrew from the study due to ARs(105 weeks)
- Proportion of BAb (binding antibodies) and NAb (neutralizing antibodies)-positive patients(105 weeks)
- Eculizumab Ctrough (steady-state eculizumab concentration at the end of the dosing interval, before the next scheduled dose, after multiple intravenous infusions of BCD-148)(105 weeks)
- Emin of serum complement hemolytic activity and C5 level (minimum serum complement hemolytic activity and C5 levels after administration of BCD-148)(105 weeks)
- Etrough of serum complement hemolytic activity and C5 level (the effect magnitude measured at the end of the dosing interval, before the next scheduled dose, at steady state after multiple intravenous infusions of BCD-148)(105 weeks)
研究者
研究点 (11)
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