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: 2024年2月29日最近更新: 2024年8月21日

适应症

试验速览

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•1 - Male and female subjects aged 18 (or the minimum country specific age of consent if >18) years or older., 2 - Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera, 3 - 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 b. Last phlebotomy due to inadequate hematocrit control within 3 months before randomization, and c. No phlebotomy within 6 days prior to randomization. Note: Phlebotomies performed within an 8-day period will be counted as a single phlebotomy, 4 - 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)., 5 - Subjects receiving cytoreductive therapy at randomization must be on a stable PV therapy regimen, 6 - Subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening.

•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.

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