NL-OMON50383已完成3 期
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) - DAHLIA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 × 109/L
- •7. Absolute neutrophil count * 0.5 x 109/L (500/*L)
- •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.
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
- •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 (eg, 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 constituents 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
- •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
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