CTRI/2019/05/019148进行中（未招募）3 期
A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity between SB12 (proposed eculizumab biosimilar) and Soliris® in Subjects with Paroxysmal Nocturnal Haemoglobinuria - SB12-3003
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
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
入选标准
- •1. Male or female aged 18 or older at the time of signing the informed consent form (ICF), if local regulations are different in this regard, follow the local regulations.
- •2. Documented diagnosis of PNH.
- •3. Presence of the PNH white blood cell (WBC) clone more than or equal to 10% by high-sensitivity flow cytometry at Screening.
- •4. Documented LDH level more than or equal to 1.5 × upper limit of normal (ULN) at Screening.
- •5. History of transfusion for anaemia within 12 months prior to Screening or having PNH-related symptoms (e.g., fatigue, haemoglobinuria, abdominal pain, chest pain, shortness of breath [dyspnoea], dysphagia, erectile dysfunction) at Screening.
- •6. All subjects must be vaccinated against Neisseria meningitidis within 3 years prior to or on Day 1 in accordance with current local guidelines or Soliris ® Summary of Product Characteristics (SmPC) to reduce the risk of meningococcal infection.
- •7. Female subjects who are not pregnant or nursing at Screening and on initiation of study drug (Day 1) and who are not planning to become pregnant from Screening until 5 months after the last dose of study drug.
- •8. Subjects and their partners of childbearing potential (female or male) who agree to use of a highly effective contraceptive method (e.g., established use of oral, injected or implanted hormonal contraceptive, placement of an intrauterine device or intrauterine system, male sterilisation, or true abstinence [see Section 8.4.1]) from Screening until 5 months after the last dose of study drug.
- •9. Subjects must be able to understand the implications of taking part in the study and be willing to follow the study instructions and requirements fully.
- •10. Subjects must be able to provide informed consent, which must be obtained prior to any study related procedures.
排除标准
- •1. Previous treatment with a complement pathway inhibitor (including eculizumab).
- •2. Known hypersensitivity to the investigational product (IP) or any of the ingredients or excipients of the IP.
- •3. Known contraindication/hypersensitivity for meningococcal vaccine or the antibiotic to be used in the study.
- •4. Abnormal haematological parameters at Screening defined as the following:
- •a. Absolute neutrophil count (ANC) less than
- •or equal to 500/mm3
- •b. Platelet count less than 70,000/mm3
- •5. History of meningococcal disease.
- •6. History of bone marrow transplantation.
- •7. History of serious thrombotic event (e.g., stroke, myocardial infarction, pulmonary embolism, etc.).
- •8. Known or suspected active bacterial, virus, fungal infection within 30 days prior to initiation of study drug (Day 1).
- •9. Known history of human immunodeficiency virus (HIV) infection or have positive results at Screening.
- •10. Concomitant use of any of the following medications is prohibited if the following conditions apply.
- •a. Erythropoietin, systemic corticosteroids, low-molecular-weight heparins, iron supplements,and androgen therapy that has not been
- •on a stable dose for at least 4 weeks prior to initiation of study drug (Day 1).
- •b. Warfarin with an unstable international normalized ratio (INR) for at least 4 weeks prior to initiation of study drug (Day 1).
- •c. Cyclosporine that has not been on a stable dose for at least 8 weeks prior to initiation of study drug (Day 1).
- •11. Subjects who have received or participated in another investigational drug, device, or procedures within 30 days or within 5 half-lives of that IP prior to Screening, whichever is greater.
- •12. History of malignancy within 5 years prior to Screening, except for curatively treated carcinoma in situ of uterine cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
- •13. Any other cardiac, hepatic, immunologic, pulmonary, rheumatoid disease, other conditions causing rise in LDH (e.g., tumours, muscular dystrophies, liver and bile disease, etc.), or the disorder which, at the discretion of the Investigator, will put the subjects at risk if they are enrolled.
- •14. Other unspecified reasons that, at the discretion of the Investigator or Sponsor, make the subjects unsuitable for enrollment.
研究者
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