jRCT2061240059招募中不适用
A Dose-Finding, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of GSK4532990 for Steatohepatitis in Adults With Alcohol-related Liver Disease (ALD)
GlaxoSmithKline K.K.0 个研究点目标入组 393 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 393
- 主要终点
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 65age old under（—）
- 性别
- All
入选标准
- •Capable of giving signed informed consent prior to the performance of any study-specific procedures.
- •Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.
- •In the opinion of the investigator, there is a history of alcohol consumption compatible with either ALD or Met ALD.
- •A female participant is eligible to participate after meeting additional pre-defined criteria.
- •Participants must meet predefined stable use requirements of concomitant medications based on study criteria.
排除标准
- •Meeting any definition of organ system failure as defined by the North American Consortium for Study of End-stage Liver Disease (NACSELD)
- •Exceeding pre-defined biochemical parameters for Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), Platelets, International normalised ratio (INR), Albumin, estimated glomerular filtration rate (eGFR), Urine albumin-creatinine ratio (UACR) or Glycosylated Hemoglobin (HbA1c). Other primary causes of liver disease based on study criteria.
- •Current or ongoing malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) at screening. Participants under evaluation for possible malignancy at screening are not eligible.
- •Prior liver transplant or current listing for liver transplant during the screening period.
- •Chronic or acute, including partial, known portal vein thrombosis.
- •Prior transjugular intrahepatic portosystemic shunt (TIPSS) insertion.
- •Any acute cardiovascular event including myocardial infarction, unstable angina, symptomatic heart failure, or cerebrovascular accident in the 6 months prior to screening.
- •Poorly controlled hypertension
- •Clinical suspicion of rhabdomyolysis during the screening period
- •Clinical suspicion of a bleeding episode during the screening period related to portal hypertension and/or low blood fibrinogen level.
- •Body Mass Index (BMI) >35 kg/m2 at screening
结局指标
主要结局
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
时间窗: up to 8 weeks
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests
时间窗: up to 8 weeks
Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests
Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan(Registered Trademark)
时间窗: at Week 28
Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan(Registered Trademark)
Change from baseline in model for end-stage liver disease (MELD) score reduction
时间窗: at Week 28
Change from baseline in model for end-stage liver disease (MELD) score reduction
次要结局
- Maximum plasma concentration (Cmax)(up to Day4)
- Area Under the Curve from Time 0 to t [AUC (0-t)](up to Day4)
- Plasma half-life (t1/2)(up to Day4)
- Apparent clearance (CL/F)(up to Day4)
- Time to maximum concentration (tmax)(up to Day4)
- Apparent terminal phase volume of distribution (Vz/F)(up to Day4)
- Area Under the Curve from Time 0 to 24 hours [AUC (0-24)](up to 24 hours)
- Change from baseline in serum AST(Week 28)
- Change from baseline in Enhanced Liver Fibrosis (ELF_trademark) score(Week 28)
- Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t)
- Maximum observed plasma concentration (Cmax)
研究者
相似试验
进行中（未招募）
不适用
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants >=18 Years of Age for the Prevention of Acute Gastroenteritis (Nova 301)jRCT2031240456ModernaTX, Inc.1,500
招募中
不适用
A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adult Patients With Relapsed/Refractory Mantle CelljRCT2031250097BeiGene, Ltd.15
招募中
不适用
A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis (J2T-MC-KGCD)jRCT2031250080Eli Lilly Japan K.K.206
招募中
不适用
A study to investigate the efficacy and safety of subcutaneous lunsekimig (SAR443765) compared with placebo in adult participants with moderate-to-severe atopic dermatitis
(VELVET)jRCT2031240665Sanofi K.K.144
招募中
不适用
A study to learn about the safety and efficacy of the drug Oleogel-S10 in Japanese patients with epidermolysis bullosa (REVIVE)jRCT2011240064Chiesi Farmaceutici S.p.A.6