A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable

Amgen Inc.0 个研究点目标入组 40 人开始时间: 2019年8月5日最近更新: 2020年12月7日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 40

研究概览入排标准研究者记录与标识符相似试验

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

•The study will enroll subjects with PNH who are stable on eculizumab treatment. Subjects cannot be enrolled or randomized before all inclusion criteria (including test results) are confirmed:
•1. Men and women = 18 years of age
•2. Historical diagnosis of PNH by documented flow cytometry
•3. Administration of eculizumab for = 6 months and currently receiving 900 mg of eculizumab every 14 ± 2 days
•4. Hemoglobin = 9.0 g/dL for at least 6 weeks prior to randomization
•5. Lactate dehydrogenase (LDH) < 1.5 × the upper limit of normal at screening
•6. Platelet count = 50 × 10^9/L
•7. Absolute neutrophil count = 0.5 x 10^9/L (500/µL)
•8. Subjects must be vaccinated against Neisseria meningitidis. Subjects must have been vaccinated or revaccinated according to current national guidelines for vaccination use.
•9. Subjects must sign an institutional review board/independent ethics committee-approved informed consent form before participation in any procedures.
•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 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

排除标准

•If any of the following apply, the subject MUST NOT enter the study:
•1. Known or suspected hereditary complement deficiency
•2. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure [New York Heart Association = Class III], serious uncontrolled cardiac arrhythmia), peripheral vascular disease, cerebrovascular accident, or transient ischemic attack in the previous 6 months
•3. Evidence of acute thrombosis (liver Doppler ultrasound of hepatic and portal veins)
•4. Known to be positive for human immunodeficiency virus
•5. Woman who is pregnant or breastfeeding
•6. Woman of childbearing potential who does not consent to use a highly effective method of birth control (e.g., true abstinence, sterilization, birth control pills, Depo Provera injections, or contraceptive implants) during treatment and for an additional 5 months after the last administration of protocol-specified treatment
•7. Man with a partner of childbearing potential who does not consent to use a highly effective method of birth control (eg, true abstinence, vasectomy, or a condom in combination with hormonal birth control or barrier methods used by the woman) during treatment and for an additional 5 months after the last administration of protocol-specified treatment
•8. Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s).
•9. Subject has known sensitivity to any constituent of the products to be administered during the study, including mammalian cell-derived drug products.
•10. History or evidence of clinically significant disorder, infection, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
•11. History of meningococcal infection
•12. Presence or suspicion of active bacterial infection, or recurrent bacterial infection.
•13. History of bone marrow transplantation
•14. Red blood cell transfusion required within 12 weeks before randomization
•15. Subject experienced = 2 breakthrough events, (ie, signs and symptoms of intravascular hemolysis, that require dose and/or schedule adjustments of eculizumab) in the previous 12 months before screening.

研究者

发起方

Amgen Inc.

相似试验

进行中（未招募）

1 期

This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.

EUCTR2017-001418-27-ESAmgen Inc.42

进行中（未招募）

1 期

EUCTR2017-001418-27-IEAmgen Inc.40

进行中（未招募）

1 期

EUCTR2017-001418-27-FIAmgen Inc.40

进行中（未招募）

1 期

This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, eculizumab, in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This study will assess if the investigational medicine is safe and effective in treating PNH compared to the licensed medicine.Paroxysmal Nocturnal Hemoglobinuria (PNH)MedDRA version: 20.1 Level: LLT Classification code 10055629 Term: Paroxysmal nocturnal hemoglobinuria System Organ Class: 100000004857

EUCTR2017-001418-27-GBAmgen Inc.40

进行中（未招募）

1 期

This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, eculizumab, in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This study will assess if the investigational medicine is safe and effective in treating PNH compared to the licensed medicine.Paroxysmal Nocturnal Hemoglobinuria (PNH)MedDRA version: 20.0 Level: LLT Classification code 10055629 Term: Paroxysmal nocturnal hemoglobinuria System Organ Class: 100000004857

EUCTR2017-001418-27-NLAmgen Inc.40