JPRN-jRCT2080225218招募中3 期
A Phase 3, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess Pharmacokinetics and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as Second Line Therapy for Essential Thrombocythemia
PharmaEssentia Corporation0 个研究点目标入组 160 人开始时间: 2020年6月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
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
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Male or female subjects greater than or equal to 18 years old
- •2. Subjects diagnosed with high-risk ET (either older than 60 years and JAK2V617-positive at screening, or having disease-related thrombosis or hemorrhage in the past), diagnosed according to the World Health Organization
- •(WHO) 2016 criteria
- •3. Subjects have received prior HU for ET, while the washout between the last dose of HU and the screening visit should not be shorter than 14 days
- •4. Interferon treatment-naive
- •5. Documented resistance/intolerance to prior HU for ET, as defined by ELN criteria (Barosi, et al, 2007), whereby at least one of the following criteria is met:
- •- Platelet count greater than 600,000/microliter at greater than or equal to 2 g/day (or greater than or equal to 2.5 g/day if subject body weight greater than 80 kg) or maximally tolerated dose if less than 2 g/day after at least 3 months of HU, or
- •- Platelet count greater than 400,000/microliter and WBC count less than 2,500/microliter at any dose and any duration of HU, or
- •- Platelet count greater than 400,000/microliter and hemoglobin (HGB) less than 10 g/dL at any dose and any duration of HU, or
- •- Presence of HU-related toxicities at any dose and any duration of therapy (e.g., leg ulcers, mucocutaneous manifestations, pneumonitis, or HU-related fever)
- •6. Platelets greater than 450,000/microliter at screening
- •7. WBC greater than 10,000/microliter at screening
- •8. HGB greater than or equal to 11 g/dL at screening for males and 10 g/dL at screening for females
- •9. Neutrophil count greater than or equal to 1,000/microliter at screening
- •10. Adequate hepatic function defined as bilirubin less than or equal to 1.5 x upper limit normal (ULN), international normalized ratio less than or equal to 1.5 x ULN, albumin greater than 3.5 g/dL, alanine aminotransferase less than or equal to 2.0 x ULN, aspartate aminotransferase less than or equal to 2.0 x ULN at screening
- •11. Creatinine clearance greater than or equal to 40 mL/min (by Cockcroft-Gault equation)
- •12. Males and females of childbearing potential, as well as all women less than 2 years after the onset of menopause, must agree to use an acceptable form of birth control until 28 days following the last dose of the study drug, and females must agree to not breastfeed during the study
- •13. Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study
排除标准
- •1. Any subject requiring a legally authorized representative
- •2. Any contraindications or hypersensitivity to IFN-alpha or ANA and their excipients
- •3. Known risk factors for QT-prolongation (e.g., congenital long QT, known history of acquired QT-prolongations)
- •4. Co-morbidity with severe or serious condition that, in the Investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol, including significant cardiac disease (including New York Heart Association Class III-IV congestive heart failure and clinically significant arrhythmias) and pulmonary hypertension
- •5. History of major organ transplantation
- •6. Pregnant or lactating females
- •7. Subjects with any other significant medical conditions that, in the opinion of the Investigator, would compromise the results of the study or may impair compliance with the requirements of the protocol, including but not limited to:
- •7-a) Documented autoimmune disease at screening or in the history (e.g., thyroid dysfunction, hepatitis, idiopathic thrombocytopenic purpura, scleroderma, psoriasis, or any arthritis of autoimmune origin)
- •7-b) Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening that, in the Investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol
- •7-c) Infections with systemic manifestations (e.g., bacterial, fungal, or human immunodeficiency virus [HIV], except hepatitis B [HBV] and/or hepatitis C [HCV], at screening)
- •7-d) Evidence of severe retinopathy (e.g., cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension)
- •7-e) History or presence of clinically relevant depression
- •7-f) Previous suicide attempts or at any risk of suicide at screening, in the judgement of the Investigator
- •7-g) History or presence of clinically significant neurologic diseases
- •7-h) History of any malignancy within 5 years (except Stage 0 chronic lymphocytic leukemia, basal cell, squamous cell, and superficial melanoma)
- •7-i) History of alcohol or drug abuse within the last year
- •7-j) History or evidence of any other (than ET) MPN
- •8. Use of any investigational drug shorter than 4 weeks prior to the first dose of study drug or not recovered from effects of prior administration of any investigational agent
- •9. Subjects with documented ANA resistance or intolerance.
研究者
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