EUCTR2015-002581-23-IT进行中（未招募）1 期
A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis - JBT101 in cystic fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 85
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
- •Documented diagnosis of cystic fibrosis
- •1. =18 and < 65 years of age at the time the Informed Consent Form is signed
- •2. FEV1 = 40% predicted, either pre- or post bronchodilator.
- •3. Stable treatment of cystic fibrosis for 14 days before Visit 1.
- •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 70
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Severe or unstable cystic fibrosis.
- •2. Any of the following values for laboratory tests at Screening
- •a. A positive pregnancy test (also Visit 1)
- •b. Hemoglobin < 10 g/dL
- •c. Neutrophils < 1.0 x 109/L
- •d. Platelets < 500 cells/µL
- •e. Creatinine clearance < 50 ml/min according to modified Cockcroft- Gault equation;
- •f. Serum transaminases > 2.5 x upper normal limit
- •g. Total bilirubin = 1.5 x upper limit of normal
研究者
相似试验
进行中（未招募）
不适用
A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromesacute coronary syndromesMedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndromeEUCTR2008-000091-24-HUTakeda Global Research & Development Centre (Europe) Ltd.2,750
进行中（未招募）
1 期
To evaluate how well study drug LX9211 is in reducing pain related to postherpetic neuralgia (PHN), a painful condition that affects the nerve fibers and skin (shingles).Postherpetic NeuralgiaMedDRA version: 21.1Level: PTClassification code 10036376Term: Post herpetic neuralgiaSystem Organ Class: 10029205 - Nervous system disordersEUCTR2020-004639-26-PLexicon Pharmaceuticals, Inc.74
进行中（未招募）
1 期
Phase 2 Study of Luspatercept in Adults with Alpha (a)-thalassemiaEUCTR2021-004928-15-GRCelgene Corporation176
已完成
不适用
Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes-I20-I21I20I21PER-056-08TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
进行中（未招募）
不适用
A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of TAK-442 in Subjects With Acute Coronary SyndromesEUCTR2008-000091-24-GBTakeda Global Research & Development Centre (Europe) Ltd.2,750