EUCTR2020-003884-25-ES进行中（未招募）1 期
An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral FT-4202, a Pyruvate Kinase Activator in Patients with Sickle Cell Disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 344
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) Provision of consent
- •2) Patient has a confirmed diagnosis of sickle cell disease
- •3) At least 2 episodes of vaso-occlusive crises in the past 12 months
- •4) Hemoglobin = 5.5 and = 10 g/dL (= 55 and = 100 g/L) during screening
- •5) Patients taking hydroxyurea, must demonstrate a stable dose for at least 90 days prior to start of study treatment
- •6) Female patients of childbearing potential must use highly effective methods of contraception, male patients are willing to use barrier methods of contraception
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 302
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Medical Conditions
- •1) More than 10 vaso-occlusive crises within the past 12 months
- •2) Female who is breast feeding or pregnant
- •3) Hepatic dysfunction characterized by:
- •- Alanine aminotransferase (ALT) > 4.0 × upper limit of normal (ULN)
- •- Direct bilirubin > 3.0 × ULN
- •4) Known HIV positive
- •5) Active hepatitis B or hepatitis C infection
- •6) Severe renal dysfunction or on chronic dialysis
- •7) History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including but not limited to the following:
- •- Unstable angina pectoris or myocardial infarction or elective coronary intervention
- •- Congestive heart failure requiring hospitalization
- •- Uncontrolled clinically significant arrhythmias
- •- Symptomatic pulmonary hypertension
- •8) History of overt clinical stroke within previous 2 years or any history of an intracranial hemorrhage
- •Prior/Concomitant Therapy
- •1) Patients receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion)
- •2) Receiving or use of concomitant medications that are strong inducers or moderate/strong inhibitors of CYP3A4/5 within 2 weeks of starting study treatment or anticipated need for such agents during the study
- •3) Use of voxelotor within 28 days prior to starting study treatment or anticipated need for this agent during the study
- •4) Use of a selectin antagonist (eg, crizanlizumab or other monoclonal antibody or small molecule) within 28 days of starting study treatment or anticipated need for such agents during the study
- •5) Use of erythropoietin or other hematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study
- •6) Receipt of prior cellular-based therapy (eg, hematopoietic cell transplant, gene modification therapy)
研究者
相似试验
尚未招募
不适用
An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral FT-4202, a Pyruvate Kinase Activator in Patients with Sickle Cell Disease (PRAISE)PACTR202202745054588Forma Therapeutics Inc.344
进行中（未招募）
1 期
This study is a randomized, placebo-controlled, double-blind, multicenter Phase 2/3 study of patients, age 12 to 65 years, with sickle cell disease (SCD).sickle cell disease (SCD)MedDRA version: 21.0Level: PTClassification code 10040644Term: Sickle cell diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2020-003884-25-DEForma Therapeutics, Inc.450
进行中（未招募）
1 期
This study is a randomized, placebo-controlled, double-blind, multicenter Phase 2/3 study of patients, age 12 to 65 years, with sickle cell disease (SCD).sickle cell disease (SCD)MedDRA version: 21.0Level: PTClassification code 10040644Term: Sickle cell diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2020-003884-25-FRForma Therapeutics, Inc.344
进行中（未招募）
1 期
This study is a randomized, placebo-controlled, double-blind, multicenter Phase 2/3 study of patients, age 12 to 65 years, with sickle cell disease (SCD).Sickle cell disease (SCD)MedDRA version: 21.0Level: PTClassification code 10040644Term: Sickle cell diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2020-003884-25-ITFORMA THERAPEUTICS, INC.344
招募中
2 期
An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral FT-4202, a Pyruvate Kinase Activator in Patients with Sickle Cell DiseaseSCDSickle Cell DiseaseLBCTR2021124934Forma Therapeutics, Inc.344