EUCTR2018-004220-11-PL进行中（未招募）1 期
A Phase 3, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PRINCE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 54
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
- •At Visit 1 screening, subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
- •1. Be at least 18 years old (inclusive).
- •2. Have LDH =1.5 x ULN at the screening visit.
- •3. Have PNH diagnosis, confirmed by high sensitivity flow cytometry (granulocyte or monocyte clone >10%).
- •4. Have Hb less than the lower limit of normal (LLN) at the screening visit.
- •5. Have ferritin greater than/equal to the LLN, or total iron binding capacity (TIBC) less than/equal to ULN at the screening visit, based on central laboratory reference ranges. If a subject is receiving iron supplements at screening, the Investigator must ensure that the subject’s dose has been stable for 4 weeks prior to screening, and it must be maintained throughout the study. Subjects not receiving iron at screening must not start iron supplementation during the course of the study.
- •6. Body mass index (BMI) = 35 kg/m2 at the screening visit.
- •7. Have a platelet count of >50,000/mm3 at the screening visit.
- •8. Have an absolute neutrophil count >500/mm3 at the screening visit.
- •9. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening and must agree to use protocol-defined methods of contraception for the duration of the study and for 90 days after their last dose of study drug.
- •10. Males must agree to use protocol-defined methods of contraception and agree to refrain from donating sperm for the duration of the study and for 90 days after their last dose of study drug.
- •11. Have vaccination against Streptococcus pneumoniae, Neisseria meningitides (types A, C, W, Y, and B), and Haemophilus influenzae (type B) either within 2 years prior to Day 1 dosing, or agree to receive vaccination 14 days after starting treatment with APL-2 (along with prophylactic antibiotic therapy for at least the 14 days between APL-2 treatment initiation and vaccination and for 14 days post vaccination). Vaccination is mandatory, unless documented evidence exists that subjects are non-responders to vaccination (as evidenced by titers or display titer levels within acceptable local limits).
- •12. Be willing and able to give informed consent.
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •Subjects will be excluded from the study if there is evidence of any of the following criteria at screening:
- •1. Treatment with any complement inhibitor (eg, eculizumab) within 3 months prior to screening.
- •2. Hereditary complement deficiency.
- •3. History of bone marrow transplantation.
- •4. Concomitant use of any of the following medications is prohibited if not on a stable regimen for the time period indicated below prior to screening:
- •Erythropoietin or immunosuppressants for at least 8 weeks
- •Systemic corticosteroids for at least 4 weeks
- •Vitamin K antagonists (eg, warfarin) with a stable international normalized ratio (INR) for at least 4 weeks
- •Iron supplements, vitamin B12, or folic acid for at least 4 weeks
- •Low-molecular-weight heparin for at least 4 weeks
- •5. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the investigational product or SC administration.
- •6. Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or 5 half-lives, whichever is longer.
- •7. Planning to become pregnant or currently a breast-feeding woman.
- •8. History of meningococcal disease.
- •9. Any comorbidity or condition (such as malignancy) that, in the opinion of the Investigator, could put the subject at increased risk or potentially confound study data.
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