EUCTR2016-004477-40-NL进行中（未招募）1 期
A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Galapagos NV
- 入组人数
- 50
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
- •Male or female subject = 18 years of age on the day of signing the ICF.
- •A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation (documented in the subject’s medical record or CF registry).
- •Weight = 40 kg during the screening period.
- •Stable concomitant medication regimen for at least 4 weeks prior to the first study drug administration and continuing the same regimen for the duration of the study.
- •FEV1 = 40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator).
- •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 49
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
- •Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 4 weeks prior to the first study drug administration.
- •Need for supplemental oxygen during the day, and > 2 L/minute while sleeping.
- •History of hepatic cirrhosis with portal hypertension (e.g. signs/symptoms of splenomegaly, esophageal varices, etc.).
- •Concomitant use of any strong inhibitor(s) or inducer(s) of CYP3A4 within 4 weeks prior to the first study drug administration.
- •Use of CFTR modulator therapy (e.g. lumacaftor or ivacaftor) within 4 weeks prior to the first study drug administration.
- •Concomitant use of CYP2C8 substrates within 4 weeks prior the first study drug administration.
- •Abnormal liver function test at screening; defined as aspartate aminotransferase (AST) and/or ALT and/or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) = 3 x the upper limit of normal (ULN); and/or total bilirubin = 1.5 x the ULN.
- •Estimated creatinine clearance < 60 mL/minute using Cockcroft-Gault equation at screening.
研究者
相似试验
进行中（未招募）
1 期
GLPG2737 on top of Orkambi in subjects with cystic fibrosisCystic fibrosisEUCTR2017-002181-42-DEGalapagos NV18
进行中（未招募）
1 期
A study to evaluate how safe MVA.HTI and ChAdOx1.HTI vaccines with vesatolimod are in participants with early treated HIV-1 infection.Human immunodeficiency virus type 1MedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2018-002125-30-ESAELIX Therapeutics50
进行中（未招募）
不适用
A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi SyndromePrader-Willi SyndromeMedDRA version: 18.0Level: HLGTClassification code 10003018Term: Appetite and general nutritional disordersSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 18.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 18.0Level: HLTClassification code 10003022Term: Appetite disordersSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2014-001670-34-ITAlize Pharma40
进行中（未招募）
1 期
A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi SyndromePrader-Willi SyndromeMedDRA version: 17.1Level: HLGTClassification code 10003018Term: Appetite and general nutritional disordersSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 17.1Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 17.1Level: HLTClassification code 10003022Term: Appetite disordersSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2014-001670-34-ESAlize Pharma40
进行中（未招募）
不适用
A Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment in patients with multiple sclerosisRelapsing multiple sclerosisMedDRA version: 14.1Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disordersEUCTR2011-004475-36-BGDelta Crystallon B.V.