A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera - VERIFY

Protagonist Therapeutics, Inc.0 个研究点目标入组 250 人开始时间: 2022年4月21日最近更新: 2024年5月13日

研究概览

暂无简介。

•1. Male and female subjects aged 18 (or the minimum country specific age of consent if >18) years or older.
•3. Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera
•4. Phlebotomy requiring defined as ALL of the following:
•a. At least 3 phlebotomies due to inadequate hematocrit control in 28 weeks before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization, and
•5. CBC values immediately prior to randomization:
•a. Hematocrit <45%,
•b. WBC 4000/µL to 20,000/µL (inclusive), and
•c. Platelets 100,000/µL to 1,000,000/µL (inclusive).
•6. Subjects receiving cytoreductive therapy at randomization must be on a stable PV therapy regimen
•7. Subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1. Clinically meaningful laboratory abnormalities at Screening
•2. Subjects who require phlebotomy at hematocrit levels lower than 45%.
•3. Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 2 months prior to randomization.
•4. Active or chronic bleeding within 2 months prior to randomization.
•5. History of invasive malignancies within the last 5 years, except a) localized cured cancer (e.g. prostate cancer and cervical cancer). b) localized cured in situ or stage 1 squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or in situ melanoma of the skin.
•6. Subjects with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of
•the skin identified during screening unless the cancer is adequately treated before randomization.
•7. Received busulfan, pipobroman or 32Phosphorus within 7 months prior to screening.

发起方