CTIS2023-506334-75-00进行中（未招募）1 期
An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH) - GB002-3102
GB002 Inc.0 个研究点目标入组 343 人开始时间: 2024年2月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 343
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Subjects must have completed a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol. 2. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) at Enrollment visit before first administration of seralutinib. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required, and results must be negative. 3. WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of seralutinib; acceptable methods include hormonal contraception (oral contraceptives – provided stable dose, patch, implant, or injection), intrauterine devices, or other form of highly effective contraception. Female subjects must refrain from egg donation throughout this period. 4. Women of nonchildbearing potential (WONCBP), classified by one of the following: a. Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, tubal ligation, Falope® rings, clips, or bands; segmental destruction of the fallopian tubes with electrocoagulation; suture ligation, a microinsert such as the Essure® system, or hysterectomy). b. Evidence of post-menopausal status. Women will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and have luteinizing hormone (LH), follicle stimulating hormone (FSH), and estradiol levels in the post-menopausal range at the Enrollment visit. 5. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of seralutinib. Male subjects must refrain from sperm donation throughout this period. 6. Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures. 7. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •1. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor’s MM (or designee). 2. Have any other condition or reason that, in the opinion of the Investigator would prohibit the subject from participating in the study.
研究者
相似试验
进行中（未招募）
1 期
Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)EUCTR2020-005169-15-ATGB002, Inc.80
进行中（未招募）
1 期
Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial Hypertension (PAH)MedDRA version: 20.0Level: LLTClassification code 10077739Term: Pulmonary arterial hypertension WHO functional class ISystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2020-005169-15-CZGB002, Inc.80
招募中
2 期
"Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1
Pulmonary Arterial Hypertension (PAH)"2024-516754-22-00GB002 Inc.11
进行中（未招募）
1 期
A open-label extension study to evaluate the long-term safety and tolerability of Sandostatin LAR in the treatment of patients with moderately severe or severe non-proliferative diabetic retinopathy (NPDR) or low risk proliferative diabetic retinopathyModerately severe or severe non-proliferative diabetic retinopathy (NPDR) or low risk proliferative diabetic retinopathyEUCTR2004-004696-11-ESovartis Farmacéutica, S.A.
进行中（未招募）
不适用
A open-label extension study to evaluate the long-term safety and tolerability of Sandostatin LAR in the treatment of patients with moderately severe or severe non-proliferative diabetic retinopathy (NPDR) or low risk proliferative diabetic retinopathyModerately severe or severe non-proliferative diabetic retinopathy (NPDR) or low risk proliferative diabetic retinopathyEUCTR2004-004696-11-ATovartis Pharma Services AG217