NCT01848925已完成1 期
A Phase I Open-label, Randomized, Safety and Efficacy Study of SANGUINATE™ at Two Doses Levels Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients.
Prolong Pharmaceuticals4 个研究点 分布在 2 个国家目标入组 24 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- To Compare SANGUINATE™ and Hydroxyurea in Sickle Cell Disease patients.
研究概览
简要总结
The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Homozygous (HbSS) Sickle Cell Anemia;
- •Hb levels: >6g/dL - <10g/dL;
- •Age : >18 years old;
- •Frequency of ER hospitalizations < 6x/yr for SCD pain events documented "medical history".
排除标准
- •Patients, who are on chronic transfusion program, defined as regular transfusions every 2-8 weeks;
- •Allergic to Hydroxyurea;
- •History of clinical significant disease, as determined by the Investigator;
- •History of allergy or major allergic reaction considered to be clinically significant by the Investigator;
- •Screening assessments considered to be abnormal by the Investigator;
- •Patient has sever pulmonary hypertension (index >3 meters per sec);
- •Donated blood within 60 days of screening or otherwise experienced blood loss of >250 mL within the same period;
- •Intending to begin new concomitant drug therapy or over-the-counter medication anytime from scree4nin to the time of administration of study drug;
研究组 & 干预措施
SANGUINATE™
Experimental
PEG-bHb-CO
干预措施: SANGUINATE™ (Biological)
Hydroxyurea
Active Comparator
Standard of care for Sickle Cell treatment, 15 mg/kg.
干预措施: Hydroxyurea (Drug)
结局指标
主要结局
To Compare SANGUINATE™ and Hydroxyurea in Sickle Cell Disease patients.
时间窗: 7 days
Compare pain management between SANGUINATE™ and Hydroxyurea using 0-10 Numeric Pain Scale.
次要结局
未报告次要终点
研究者
研究点 (4)
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