EUCTR2011-002393-23-GB进行中（未招募）1 期
A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Human Antihaemophilic Factor VIII (rFVIII; INN: octocog alfa) in Subjects with Hemophilia A, and a Repeat PK, Safety and Efficacy Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 174
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
入选标准
- •- Diagnosis of severe hemophilia A defined as <1% FVIII:C documented in medical records.
- •- Males between = 12 and 65 years of age (Part 3).
- •- Subjects who have received or are currently receiving FVIII products (plasma-derived and/or recombinant FVIII) and have had
- •>150 EDs with a FVIII product
- •- Written informed consent for study participation obtained before undergoing any study specific procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 81
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Any history of or current FVIII inhibitors
- •- Any first order family history of FVIII inhibitors
- •- Use of an Investigational Medicinal Product within 30 days prior to the first CSL627 administration
- •- Not capable of receiving treatment at home
- •- Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to administration of CSL627 or reference product.
- •- Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein.
- •- Any known congenital or acquired coagulation disorder other than congenital FVIII deficiency.
- •- Platelet count < 100,000/µL at screening.
- •- HIV positive subjects with a CD4 count < 200/mm3, in their medical history or at screening if available results are older than one year. (HIV positive subjects may participate in the study and antiviral therapy are permitted, at the discretion of the Investigator).
- •- Subject currently receiving IV immunomodulating agents such as chronic systemic corticosteroid treatment.
- •- Subject with serum aspartate aminotransferase or serum alanine aminotransferase values > 5 times (x) the upper limit of normal (ULN) at Screening.
- •- Subjects with serum creatinine values > 2 x ULN at Screening.
- •- Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to Day 1.
- •- Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to Day 1.
- •- Demonstrated inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance.
- •- Employee at the study site, or spouse/partner or relative of the investigator.
- •- Re-entry of subjects previously enrolled or participating in the current study.
- •- Suspected inability (eg, language problems) or unwillingness to comply with study procedures.
- •- Mental condition rendering the subject (or subject's legally acceptable representative[s])unable to understand the nature, scope and possible consequences of the study.
- •- Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study.
研究者
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