EUCTR2018-002565-18-ES进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Combination Therapy of SCY-078 with Voriconazole in Patients with Invasive Pulmonary Aspergillosis (SCYNERGIA) - SCYNERGIA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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. Subject is a male or female adult =18 years of age on the day the study informed consent form (ICF) is signed.
- •2. Subject has a possible, probable or proven IPA based on EORTC-MSG criteria.
- •3. Subject has a result of a serum GMI =0.5 from a sample obtained within the 96 hours preceding enrollment into the study (Baseline/Treatment Day 1).
- •4. Subject has a diagnosis of a hematological malignancy or a myelodysplastic syndrome or aplastic anemia or has undergone hematopoietic cell transplantation.
- •5. Subject has not received more than 4 days (96 hours) of prior mold-active antifungal 12 NOV 2018 CONFIDENTIAL Page 22
- •therapy for the treatment of the IPA episode in the 7 days preceding enrollment into the study (Baseline/Treatment Day 1). However, subjects who have received more than 4 days but less than 7 days of prior mold-active antifungal therapy for the treatment of the IPA episode in the 7 days preceding enrollment into the study may be enrolled but will require approval from the study medical monitor, who will evaluate each subject on a case-by-case basis.
- •6. Subject has an IPA episode that, in the investigator´s judgement, requires antifungal therapy and may be adequately treated with voriconazole (i.e., the IPA is not a breakthrough infection while receiving a mold-active azole antifungal [voriconazole, posaconazole, isavuconazole or itraconazole] that requires therapy with a non-azole antifungal agent).
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Subject has a fungal disease with central nervous system involvement suspected at Screening.
- •2. Subject is receiving, has received or anticipates to be receiving concomitant medications that are listed in the prohibited medication list (Appendix A in full protocol) within the specified washout periods.
- •3. Subject has a Karnofsky score <20.
- •4. Subject is expected to die from a non-infectious cause within 30 days from the day the study ICF is signed.
- •5. Subject is under mechanical ventilation.
- •6. Subject has abnormal liver test parameters: AST or ALT >10 x ULN and/or total bilirubin >5 x ULN.
- •7. Note: Subjects with unconjugated hyperbilirubinemia with a diagnosis of Gilbert’s disease are not excluded.
研究者
相似试验
进行中（未招募）
1 期
A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK-0431 to Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy - MK-0431 Metformin Add-on StudyMedDRA version: 7.0 Level: LLT Classification code 10045242Type 2 Diabetes MellitusEUCTR2004-000312-93-BEMerck Sharp & Dohme BV525
进行中（未招募）
1 期
A Blinded Study to Evaluate Higher Versus Standard Adalimumab Doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlceratioMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersCrohn's diseaseEUCTR2013-001746-33-BEAbbVie Deutschland GmbH & Co. KG514
进行中（未招募）
1 期
A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlceratioMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersCrohn's diseaseEUCTR2013-001746-33-ATAbbVie Deutschland GmbH & Co. KG500
已完成
3 期
Efficacy and Safety Study of Alogliptin Compared to Glipizide in Elderly DiabeticsCTRI/2009/091/000123Takeda Global Research & Development Centre (Europe) Ltd (TGRD)61 AldwychLondon WC2B 4AE United Kingdom
进行中（未招募）
不适用
A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic ControlType II Diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusEUCTR2007-003548-32-LTMerck & Co., Inc.500