EUCTR2012-002318-37-IT进行中（未招募）1 期
Polycythemia Vera Symptom Study Evaluating Ruxolitinib Versus Hydroxyurea in a Randomized, Multicenter, Double-Blind, Double-Dummy, Phase 3 Efficacy and Safety Study of Patient Reported Outcomes - The RELIEF Study
INCYTE0 个研究点目标入组 100 人开始时间: 2012年12月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Men or women aged . 18 years with a confirmed diagnosis of PV
- •according to the revised World Health Organization criteria.
- •. Subjects must currently be reporting symptoms on a stable dose of HU
- •monotherapy and be eligible to continue HU on study after
- •randomization. Before screening, the subject must have been receiving
- •HU for at least 12 weeks and on the same dose for the last 4 weeks.
- •. Subjects must have completed the modified MPN-SAF screening
- •symptom form and have a screening total symptom score (TSS) of . 8
- •for the cytokine-related symptoms, or symptom cluster C (TSS-C):
- •tiredness, itching, muscle aches, night sweats, and sweats while awake.
- •. Subjects should meet at least one of the following criteria with respect
- •to phlebotomy and splenomegaly:
- •. No more than 1 phlebotomy within the 6 months before screening OR
- •. No palpable splenomegalym
- •Subjects must have a hematocrit that can be controlled within 35% to
- •48% (inclusive) before randomization. (A phlebotomy may be performed
- •during the screening phase to achieve this target range.)
- •Subjects must have recovered from all side effects associated with
- •phlebotomy, and at least 1 week must have elapsed between the
- •phlebotomy and the beginning of the baseline phase.
- •Subjects with Eastern Cooperative Oncology Group performance status
- •of 0, 1, or 2 at screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Subjects with inadequate liver or renal function at screening as
- •demonstrated by:
- •. Encephalopathy . Grade 2 as per Child-Pugh System
- •. Hepatocellular disease
- •. Total bilirubin > 2 ~ upper limit of normal (ULN), unless direct
- •bilirubin is < 2 ~ ULN
- •. Alanine aminotransferase > 2.5 ~ ULN
- •. Modification of Diet in Renal Disease estimated glomerular filtration
- •rate < 30 mL/min/1.73 m2 or on dialysis
- •. Subjects with platelet count < 100 ~ 10^9/L or an absolute neutrophil
- •count of < 1 ~ 10^9/L
- •. Subjects with peripheral blood blast count of > 0% at screening.
研究者
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