EUCTR2017-004045-25-IT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 - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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 Patients with Sickle Cell Disease Who Have Participated in GBT440 Clinical TrialsMedDRA version: 20.0Level: LLTClassification code 10040644Term: Sickle cell diseaseSystem Organ Class: 100000004850Sickle Cell DiseaseEUCTR2017-004045-25-FRGlobal Blood Therapeutics, Inc.435
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