Efficacy and safety of FPF300 for epistaxis in Hereditary Hemorrhagic Telangiectasia(HHT) : A Phase IIa Study

Fujimoto Pharmaceutical Corp.0 个研究点目标入组 8 人开始时间: 2021年3月24日最近更新: 2022年7月5日

试验速览

暂无简介。

•Patients who have diagnosed as definite HHT by the Curacao criteria
•Patients who have exceeded 4 points by Epistaxis Severity Score and have epistaxis at least three times a week on average since 4weeks before patient's consent
•Patients whose age are 20 or older at the time of their consent
•Patients who adhere to FPF300 risk management system

•Women in pregnancy, breastfeeding or child bearing
•Men who wish their partners to become pregnant during the study period
•Patients who have previously been prescribed the following agents
•a) thalidomide and derivatives (lenalidomide and pomalidomide)
•b) angiogenesis inhibitors (e.g. bevacizumab, pazopanib)
•Patients who have the medical history(except for a)) or complications below
•a) anemia by reason of other than HHT
•b) hemorrhagic disease (e.g. hemophilia) by reason of other than HHT
•c) pulmonary embolism / deep vein thrombosis
•d) bradycardic arrhythmia
•e) heart failure
•f) pulmonary hypertension
•g) active cancer within 5 years of disease free interval
•BNP >= 100 pg/mL or NT-pro BNP >= 400 pg/mL
•Patients who have a high risk of deep vein thrombosis
•Patients who are positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody

Improvement rate of Epistaxis Severity Score

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