EUCTR2019-004471-39-IT进行中（未招募）1 期
A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- IMARA Inc.
- 入组人数
- 99
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
- •1.Male or female aged =18 to =65 years at the time of informed consent form (ICF) signing.
- •2.Confirmed diagnosis of SCD (HbSS, HbSB0 thalassemia, or HbSB+thalassemia) in the medical record; if not available, the diagnosis must be confirmed at the site's local laboratory instead.
- •3.Subjects must have had at least 1 and no more than 12 documented episodes of VOC in the past 12 months at the time of ICF signing and at
- •randomization (Day 1). For study eligibility, VOC is defined as a documented episode of an acute painful crisis (for which there was not an explanation other than VOC) that involved moderate to severe pain lasting for at least 2 hours and at least one of the following:
- •Use of escalated analgesia (including healthcare professionalinstructed use of an analgesic prescription)
- •A hospital, emergency department, or clinic visit and/or healthcare telephone consultation at the time of occurrence
- •Diagnosis of acute chest syndrome (ACS) (defined as an acute illness characterized by fever and/or respiratory symptoms, accompanied by a new pulmonary infiltrate on a chest X ray), hepatic sequestration, or splenic sequestration
- •4.Hemoglobin (Hb) of >5.5 and <10.5 g/dL.
- •5.Absolute reticulocyte count =80 × 10^9/L.
- •6.Subjects receiving HU must have received it continuously for at least 6 months prior to signing the ICF, and must have been on a stable dose for at least 3 months prior to signing the ICF, with no anticipated need for dose adjustments during the study including the screening period, in the opinion of the investigator.
- •7.Female subjects must not be pregnant or breastfeeding and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner [etc...].
- •8.Be capable of giving informed consent and reading and signing the ICF after the nature of the study has been fully explained by the investigator or investigator designee.
- •9.Be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 97
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Hospital discharge for sickle cell crisis or other vaso occlusive event within the 4 days prior to randomization (Day 1).
- •2.Red blood cell transfusion within 60 days of signing the ICF or on chronic transfusion therapy regimen. Transfusion status must be reassessed at randomization (Day 1). Note: If a subject requires a transfusion during the screening period, they may be rescreened up to one time.
- •3.Subjects with hereditary persistence of HbF (i.e., HbF >25% at screening).
- •4.Subjects with known active hepatitis A, hepatitis B, or hepatitis C, with active or acute event of malaria, or who are known to be positive for human immunodeficiency virus (HIV).
- •5.For female subjects of childbearing potential, a positive serum human chorionic gonadotropin (hCG) test (screening) or a positive urine hCG test at randomization (Day 1).
- •6.Estimated glomerular filtration rate (eGFR) <45 mL/min as calculated by the equation from the Modification of Diet in Renal Disease Study using creatinine, age, sex, and ethnicity.
- •7.Alanine aminotransferase or aspartate aminotransferase >3 x the upper limit of normal.
- •8.Body mass index (BMI) <17.0 kg/m2 and a total body weight <45 kg; or a BMI >35 kg/m2.
- •9.Current or history of malignancies (solid tumors and hematological malignancies), unless the subject has been free of the disease (including completion of any active or adjuvant treatment for prior malignancy) for =5 years. However, subjects with the following history/concurrent conditions are allowed if, in the opinion of the investigator, the condition has been adequately diagnosed and is determined to be clinically in remission, and the subject's participation in the study would not
- •represent a safety concern:
- •a.Basal or squamous cell carcinoma of the skin
- •b.Carcinoma in situ of the cervix
- •c.Carcinoma in situ of the breast
- •d.Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis clinical staging system)
- •10.A history of a clinically significant allergic reaction or hypersensitivity, as judged by the investigator, to any drug or any component of the study drug formulations used in the study (see Investigator's Brochure).
- •11.History of unstable or deteriorating cardiac or pulmonary disease within 6 months before signing the ICF, including but not limited to the following:
- •a.Unstable angina pectoris or myocardial infarction or elective coronary intervention
- •b.Congestive heart failure requiring hospitalization
- •c.Uncontrolled clinically significant arrhythmias
- •12.Any condition affecting drug absorption, such as major surgery involving the stomach or small intestine (prior cholecystectomy is acceptable).
- •13.On ECG testing at ICF signing and/or randomization (Day 1), a corrected QT interval, Fridericia's formula (QTcF) >450 ms in men and >470 ms in women or the presence of clinically significant ECG abnormalities as determined by the investigator.
- •14.A history of major surgery within 4 weeks or minor surgery within 2 weeks of randomization (Day 1).
- •15.Stroke requiring medical intervention within 24 weeks prior to randomization (Day 1).
- •[Please refer to the protocol for exclusion criteria 16-27]
研究者
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