An Open-label Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia) Who Participated in Study IMR-SCD-102
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Imara, Inc.
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Proportion of patients with clinically significant abnormal vital signs
研究概览
简要总结
This is an open-label extension study of IMR-687 in adult patients who completed Imara's blinded Phase 2a study (IMR-SCD-102). The open-label extension study will evaluate long-term safety and tolerability.
详细描述
This is an open-label extension study of IMR-687 in adult patients with SCA who were previously participants in the Phase 2a study titled "A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients with Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)."
This open-label extension study with IMR-687 will evaluate the long-term safety and tolerability of IMR 687 in adult SCA patients. Exploratory long-term PD parameters will also be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed Study IMR-SCD-
- •Female subjects must not be pregnant, not be breast feeding, and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner.
- •Subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained to them
- •Subjects must be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff.
排除标准
- •Subjects with Hb >12.5 g/dL or <6 g/dL
- •Subjects with known active hepatitis B or hepatitis C, with active or acute event of malaria or who are known to be positive for human immunodeficiency virus (HIV)
- •eGFR <50 mL/min
- •AST/ALT > 3x the upper limit of normal
研究组 & 干预措施
Open Label
干预措施: IMR-687 (Drug)
结局指标
主要结局
Proportion of patients with clinically significant abnormal vital signs
时间窗: Baseline to Month 49
1. Blood pressure measured in mmHg 2. Pulse measured in beats per minute 3. Respiration rate measured in breaths per minutes 4. Temperature as measured in degrees F0 or C0
Proportion of patients with adverse events and serious adverse events
时间窗: Baseline to Month 49
1. Incidence of Adverse Events 2. Incidence of Serious Adverse Events
Proportion of patients with changes in safety cardiac parameters
时间窗: Baseline to Month 49
a. Changes in 12-lead ECG parameters that are clinically significant and measured in milliseconds (ms). The parameters are: PR interval, QRS duration, QT interval, ST segment duration and T wave duration.
Proportion of patients with changes in clinical laboratory tests
时间窗: Baseline to Month 49
a. Clinically significant changes in clinical laboratory tests including serum chemistry, serum hematology and urinalysis
次要结局
未报告次要终点