EUCTR2017-004045-25-FR进行中（未招募）1 期
An Open Label Extension Study of GBT440 Administered Orally to Patients with Sickle Cell Disease Who Have Participated in GBT440 Clinical Trials
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 435
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 study participants with SCD who participated and received study treatment in Study GBT440-031.
- •Note: Participants in GBT440-031 who discontinued study drug due to an AE, but who remained on study may be eligible for treatment in this study provided the AE does not pose a risk for treatment with GBT440.
- •2. Females of child-bearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1.
- •3. Female participants of child-bearing potential must use highly effective methods of contraception to 30 days after the last dose of study drug. Male participants must continue to use barrier methods of contraception to 30 days after the last dose of study
- •4. Participant has provided written informed consent or assent (the ICF must be reviewed and signed by each participant; in the case of pediatric participants, both the consent of the participant’s legal representative or legal guardian, and the participant’s assent must be obtained).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 335
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Female who is breast-feeding or pregnant.
- •2. Participant withdrew consent from Study GBT440-031.
- •3. Participant was lost to follow-up from Study GBT440-031.
- •4. Participant requiring chronic dialysis.
- •5. Any medical, psychological, safety, or behavioral conditions, which, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.
研究者
相似试验
Unknown
3 期
Study to Assess the Effect of Long-term Treatment With GBT440 in Participants Who Have Completed Treatment in Study GBT440-031Anemia, Sickle Cell, Hemolytic, Congenital, Hemoglobinopathies, Genetic Diseases, InbornSickle Cell DiseaseLBCTR2019080216Global Blood Therapeutics, Inc6
进行中（未招募）
1 期
An Open Label Extension Study of GBT440 Administered Orally to Patientswith Sickle Cell Disease Who Have Participated in GBT440 Clinical TrialsMedDRA version: 20.1Level: LLTClassification code 10002077Term: Anaemia sickle cellSystem Organ Class: 100000004850MedDRA version: 20.1Level: LLTClassification code 10055200Term: Anemia sickle cellSystem Organ Class: 100000004850Sickle Cell DiseaseEUCTR2017-004045-25-ITGLOBAL BLOOD THERAPEUTICS, INC.120
进行中（未招募）
1 期
An Open Label Extension Study of GBT440 Administered Orally to Patients with Sickle Cell Disease Who Have Participated in GBT440 Clinical TrialsMedDRA version: 20.0 Level: LLT Classification code 10040644 Term: Sickle cell disease System Organ Class: 100000004850Sickle Cell DiseaseEUCTR2017-004045-25-GBGlobal Blood Therapeutics, Inc.435
招募中
1 期
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without InhibitorsHaemophiliaMedDRA version: 20.0Level: LLTClassification code: 10018937Term: Haemophilia A Class: 10010331MedDRA version: 20.0Level: LLTClassification code: 10018938Term: Haemophilia A (Factor VIII) Class: 10010331MedDRA version: 20.0Level: LLTClassification code: 10018939Term: Haemophilia B (Factor IX) Class: 10010331CTIS2022-500470-33-00Pfizer Inc.145
进行中（未招募）
1 期
A study of long term treatment with PTG-300 for patients with thalassemia who were treated with PTG-300 previouslyEUCTR2018-004423-36-GRProtagonist Therapeutics, Inc.84