EUCTR2019-002324-32-IT进行中（未招募）1 期
A randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor (LJN452) & licogliflozin (LIK066) combination therapy, compared to each monotherapy, for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis (ELIVATE) - NA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 233
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
- •Presence of NASH as demonstrated by the following: NASH with fibrosis stage 2 or 3 confirmed by central reader's evaluation using NAFLD Activity Score (NAS) and NASH CRN criteria, of liver biopsy obtained no more than 6 months before randomization.
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Type 1 diabetes mellitus
- •Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) = 9.5% at screening
- •HbA1c < 6.5% at screening in Type 2 diabetics currently treated with insulin or sulfonylureas
- •Clinical evidence of liver impairment as defined by the presence of any of the following abnormalities:
- •¿Abnormal platelet count
- •¿Serum albumin < 3.2g/dL
- •¿International Normalized Radio (INR) > 1.3
- •¿ALT or AST > 5xULN
- •¿Total bilirubin >1.3 mg/dL (22 µmol/L) (including Gilbert's syndrome)
- •¿Alkaline phosphatase > 300 IU/L
- •¿History of esophageal varices, ascites or hepatic encephalopathy
- •¿Splenomegaly
研究者
相似试验
进行中（未招募）
1 期
Assess safety and efficacy of vilaprisan in subjects with endometriosisPre-menopausal women 18 years and older with confirmed endometriosis and moderate to severe endometriosis-associated pelvic pain (EAPP), otherwise in good general health.MedDRA version: 20.0Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disordersEUCTR2013-004768-72-DEBayer AG315
进行中（未招募）
1 期
Study of safety, tolerability and efficacy of a combination treatment of tropifexor (LJN452) & licogliflozin (LIK066) and each monotherapy, compared with placebo in adult participants with nonalcoholic steatohepatitis (NASH) and liver fibrosisEUCTR2019-002324-32-SKovartis Pharma AG380
招募中
2 期
Clinical trial to compare the efficacy and tolerability of fulvestrant (FaslodexTM) 500mg with placebo versus fulvestrant (FaslodexTM) 500mg with PD-0332991 (Palbociclib), randomly assigned, as first line treatment for postmenopausal women with hormone receptor-positive metastatic breast cancer, who have completed at least 5 years of hormonal therapy and remained disease free for more than 12 months following its completion or who have metastatic disease diagnosed from the beginning.Metastatic breast cancer2024-516132-10-00Fundacion Grupo Espanol De Investigacion En Cancer De Mama189
进行中（未招募）
1 期
Assess safety and efficacy of vilaprisan in subjects with endometriosisEUCTR2013-004768-72-ESBayer AG315
进行中（未招募）
不适用
A randomized, double-blind, parallel-group, multicenter study to demonstrate improvement in symptoms of constipation in subjects with non-malignant pain taking oxycodone equivalent of >= 20 mg/day and <= 50 mg/day as oxycodone / naloxone prolonged release compared to subjects taking oxycodone prolonged release tablets alone.Moderate to severe non-malignant pain that requires around the clock opioid therapy and also have constipation secondary to opioid treatment.MedDRA version: 8.1Level: LLTClassification code 10049475Term: Chronic painEUCTR2005-002398-57-CZMundipharma Research GmbH & Co. KG600