Double-blind, placebo-controlled study and open label study of FPF300 for epistaxis in Hereditary Hemorrhagic Telangiectasia(HHT) : A Phase III Study

Fujimoto Pharmaceutical Corporation0 个研究点目标入组 44 人开始时间: 2023年11月27日最近更新: 2024年6月7日

试验速览

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•Patients who have diagnosed as definite HHT by the Curacao criteria, or certified as designated intractable diseases 227(HHT)
•Patients with an Epistaxis Severity Score (ESS) >= 4.01 who have epistaxis at least three times a week on average since 4weeks before initial patient's consent
•Patients 18 or older at the time of their initial 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 thalidomide
•Patients who have been prescribed the following agents since 12months before initial patient's consent
•a) thalidomide 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 >= 300 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

The changing of Epistaxis Severity Score compared to baseline Adverse event

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发起方

Fujimoto Pharmaceutical Corporation