CTRI/2024/01/062031尚未招募2 期
A Global, Open-label Study to Investigate the Efficacy and Safety of SerpinPC in Subjects With Hemophilia B With Inhibitors - PRESent-3
ApcinteX Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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 subjects =12 and =65 years of age at the time of informed consent
- •2.Capable of providing written informed consent (adolescent assent and parental/guardian/legal representative consent when appropriate) for participation and having the opportunity to discuss the study with the Investigator or delegate
- •3.Historically documented HemB (defined as factor IX =0.05 IU/mL [=5%])
- •4.Subjects who are currently in a prophylaxis program must be willing to stop prophylaxis (including episodic prophylaxis for sporting events) before the first dose of SerpinPC
- •5.Historical or ongoing Factor IX inhibitor requiring current treatment with bypass agents based on medical records or laboratory reports
- •6.Documented ABR of =6 in the 12 months before screening (subjects not on prophylaxis regimen) or documented ABR of =2 for subjects on prophylaxis regimen
- •7.At least 12 weeks of prospective documentation of bleeding episodes in the AP-0105 non-interventional study before SerpinPC dosing, or willing to complete a 12-week observational period (at minimum) in AP-0103
- •8.No bleeding in the 7 days before Baseline (the prospective observation period can be extended by 10 days if there is an ongoing active bleed)
- •9.D-dimer of =750 µg/L; in cases where there is a resolving bleed, the exclusion threshold is =1750 mg/L at Screening and Pre-dosing visits
- •10.Adequate hematologic function, defined as a platelet count of =100,000/µL (=100 × 109/L) and hemoglobin level of =10 g/dL (=100 g/L or
排除标准
- •1.Known severe thrombophilia (defined as antithrombin deficiency and/or protein S deficiency and/or protein C deficiency)
- •2.Patient with previous factor IX inhibitor who responded to immune tolerance induction and remains on prophylactic factor concentrate
- •3.Previous deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke
- •4.History of intolerance to SC injections
- •5.Uncontrolled hypertension (systolic blood pressure >160 mm Hg; diastolic blood pressure >100 mm Hg)
- •6.Weight >150 kg OR body mass index >40 kg/m2
- •7.Has active cancer and/or requires therapy for cancer, except for basal cell carcinoma
- •8.Participation in another clinical trial (except for AP-0105) during the 30 days before screening
- •9.Prior, ongoing, or planned treatment with gene therapy for HemB
- •10.Any major medical, psychological, or psychiatric condition that could cause the subject to be unsuitable for the study or could interfere with the interpretation of the study results
- •11.History of or other evidence of recent alcohol or drug abuse as determined by the Investigator (in the 12 months before screening)
- •12.Known HIV infection with CD4 count (or T-cell count) of <200 cells/µL within 24 weeks before Screening and Pre-dosing visits. Patients with HIV infection who have CD4 > 200 and meet all other criteria are eligible
- •13.Current or planned treatment with anticoagulant or antiplatelet drugs
- •14.Is planning to donate/bank sperm during SerpinPC treatment AND within 30 days of last dose of SerpinPC
- •15.Any other significant conditions or comorbidities that, in the opinion of the Investigator, would make the subject unsuitable for enrollment, or could interfere with participation in or completion of the study.
研究者
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