EUCTR2015-001617-27-IT进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 145
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
- •Systemic sclerosis according to ACR/EULAR 2013 criteria
- •Diffuse cutaneous SSc subset (LeRoy’s criteria)
- •Diagnosis within the past 3 years as defined by the first non-Raynaud’s symptom
- •MRSS between 10 and 25
- •Aged between 18 and 75 years
- •Informed consent documented by signature
- •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 85
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Unstable treatment with corticosteroids or immunosuppressive agents (stable therapy for more than 3 months with prednisone = 10 mg, methotrexate= 20 mg/w, azathioprine = 150 mg/d, mycofenolate mofetil = 2g/d, or leflunomide = 20 mg/d is acceptable)
- •Cyclophosphamide during the past 6 months
- •Requirement of IV prostanoids for critical ischemia or pulmonary hypertension in the last 3 months
- •Renal insufficiency defined by a creatinine clearance of less than 30 ml/min and/or past/current renal crisis
- •Hepatic impairment i.e. primary biliary cirrhosis and unexplained persistent liver function abnormality,
- •Gallbladder disease
- •Severe cardiac (LVEF <45%) and/or pulmonary disease (FVC < 50% or pulmonary hypertension proven by right heart catheterisation)
- •History of heart failure, symptomatic coronary artery disease, significant ventricular tachyarrhythmia, stent placement, coronary artery bypass surgery, and/or myocardial infarction.
- •Recipient of solid organ transplant
- •Gastrointestinal involvement preventing oral administration of study drug
- •Chronic infections, positive serology for infection with hepatitis B or C.
- •Pregnancy, Lactation. Woman of childbearing potential unwilling to use a medically acceptable form of birth control
- •History of malignancy within the last 5 years, except for resected basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ cervical cancer
- •A recent history of alcohol or drug abuse, non-compliance with other medical therapies
- •Participation in a clinical study involving another investigational drug or device within 4 weeks before the Pre-treatment Visit
- •Laboratory parameters at the pre-treatment visit showing any of the following abnormal results: transaminases > 2x the upper limit of normal (ULN) and/or bilirubin > 2x ULN; neutrophil count < 1,500/mm3; platelet count < 100,000/mm3; haemoglobin < 9 g/dL
- •Contraindications to the class of drugs under study (PPAR agonists), e.g. known hypersensitivity or allergy to class of drugs or the investigational product (see IB 2015)
- •Any condition or treatment, which in the opinion of the investigator, places the subject at unacceptable risk as a patient in the trial (Please consider the precautions and warnings described in the IB 2015)
研究者
相似试验
进行中（未招募）
1 期
Study on the safety of the drug runcaciguat and how well it works when given at the highest dose as tolerated by the individual patient whose kidneys are not working properly and suffering at the same time from a disease of the heart and the blood vessels and high blood sugarTreatment of cardiovascular and renal disease in patients with chronic kidney diseaseMedDRA version: 21.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.0Level: PTClassification code 10001580Term: AlbuminuriaSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2019-003297-53-ESBayer AG432
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and tolerability of licarbazepine 750-2500 mg/d combined with risperidone in the treatment of manic episodes of bipolar I disorder over 6 weeksBipolar I disorder, manic and mixed episodesEUCTR2004-000113-18-HUovartis Hungaria Kft.430
进行中（未招募）
1 期
Phase 2b dose-ranging study of ALX-0171 in infants and young children hospitalized for RSV lower respiratory tract infectioRSV lower respiratory tract infectionMedDRA version: 20.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2016-001651-49-SKAblynx NV180
进行中（未招募）
1 期
A randomized, double-blind, placebo-controlled, multicenter phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients have achieved complete response with first-line rituximab-chemotherapyDiffuse Large B-Cell LymphomaMedDRA version: 19.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-000498-40-HUovartis Pharma Services AG487
进行中（未招募）
1 期
Safety and efficacy study in patients with moderate to severe nail psoriasisModerate to severe nail psoriasisMedDRA version: 18.0Level: PTClassification code 10028703Term: Nail psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2012-005413-40-BEovartis Pharma Services AG195