jRCT2031240541尚未招募不适用
A Phase III double-blind, randomised, placebo-controlled trial to evaluate liver-related clinical outcomes and safety of once weekly injected survodutide in participants with compensated non-alcoholic steatohepatitis/metabolic dysfunction associated steatohepatitis (NASH/MASH) cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 126
- 主要终点
- Time to first occurrence of any component of the composite clinical endpoint
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
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or female adults >=18 years of age at the time of screening, and at least the legal age of consent in countries where it is >18 years
- •BMI >=27 kg/m2(>=25 kg/m2 for Asian trial participants)
- •Compensated MASH cirrhosis diagnosed according to modified Liver Forum criteria (Noureddin et al, Gastroenterology 2020;159:422-427).
- •MRI-PDFF fat fraction >=5% or FibroScan with CAP >=288 dB/m, obtained during the screening period or a historic MRI-PDFF or FibroScan with CAP <=12 weeks prior to randomisation (except for patients with "cryptogenic cirrhosis" where MRI-PDFF <5% or FibroScan with CAP < 288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (<=12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis.
- •Further inclusion criteria apply
排除标准
- •Liver related
- •Current or history (<5 years) of significant alcohol consumption, defined as an average of > 140 g/week in female patients and >210 g/week in male patients, for a period of >3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.
- •MELD score >12 due to liver disease
- •History or current (i.e. at screening) hepatic decompensation event defined as presence of any of the following but not limited to:
- •History of portal hypertension-related upper GI bleeding
- •HE >=Grade 1 according to the West Haven criteria [
- •Any of the following lab test result at screening:
- •Albumin below <3.5 g/dL (<35.0 g/L)
- •INR >1.3 unless due to therapeutic anticoagulants
- •TBL >1.2x ULN
- •NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL >1.2x upper limit of normal (ULN) if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is <20% of TBL.
- •Alkaline phosphatase >1.5x ULN
- •Platelet count <100,000/uL (<100 GI/L)
- •History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis
- •Hepatitis B positive (defined as positive HBsAg)
- •Hepatitis C positive (defined as positive HCV antibody and a positive HCV RNA).
- •Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
- •Serum AST and/or ALT >5x ULN
- •History of liver transplantation or listed for liver transplantation
- •History of TIPS or other radiological/surgical procedure for portal hypertension treatment
- •Further exclusion criteria apply
结局指标
主要结局
Time to first occurrence of any component of the composite clinical endpoint
时间窗: at EoS
Composite clinical endpoint consisting of: - All-cause mortality - Liver transplant - Hepatic decompensation events - Worsening of MELD score to >=15 - Progression to CSPH
次要结局
未报告次要终点
研究者
相似试验
招募中
不适用
A study to test whether spesolimab helps people with a skin condition called pyoderma gangrenosumpyoderma gangrenosumjRCT2041240157Boehringer Ingelheim90
尚未招募
Unknown
Prospective study to test the effectiveness of surgery for improving function of swallowing in head and neck cancer patients using high-resolution manometryJPRN-UMIN000053236Japanese Foundation for Cancer Research30
尚未招募
不适用
A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic DiseasesjRCT2071240117Boehringer Ingelheim400
进行中（未招募）
不适用
Ensayo clínico para evaluar la eficacia de los suplementos de progesterona natural en la prevención del parto pretérmino gemelarEUCTR2004-004136-31-ESaboratorios Effik, S.A.
已完成
不适用
Oxidative stress markers and insulin pump therapyType 1 diabetesISRCTN12081042niversity of the Highlands and Islands (UK)48