NCT06675929已完成2 期
Safety, Tolerability and Pharmacodynamics of BI 770371 Administered Intravenously in Patients With Compensated Cirrhosis Due to MASH: a Phase IIa, Multi-center, Randomized, Double-blind, Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 25
- 主要终点
- Occurrence of treatment-emergent, drug-related adverse events in the BI 770371 and placebo arms
研究概览
简要总结
This study is open to people with cirrhosis caused by a liver disease called MASH (metabolic dysfunction-associated steatohepatitis). The purpose of this study is to find out how well a medicine called BI 770371 is tolerated.
Participants are put into 2 groups by chance. One group gets BI 770371 as an infusion into a vein and the other group gets placebo as an infusion into a vein. Placebo infusions look like BI 770371 infusions but do not contain any medicine. Participants get an infusion every 3 weeks for 12 weeks.
Participants are in the study for about 5 months. During this time, they visit the study site 16 times. This also includes 1 overnight stay at the study site. The doctors regularly check participants' health and collect information on any health problems of the participants. The results are compared between the 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 to ≤75 years old
- •Male or female participants
- •Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information
- •Men able to father a child must be willing to use male contraception (condom or sexual abstinence) consistently and correctly until end of study. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information
- •Signed and dated written informed consent in accordance with ICH-Good Clinical Practice (GCP) and local legislation prior to admission to the trial
- •Patients meeting criteria for Child-Pugh category A
- •Adequate organ function or liver laboratory tests defined as all of the following:
- •Total bilirubin ≤1.5 mg/dL. If the total bilirubin is > upper limit of normal (ULN) and a ≤1.5 mg/dL, the direct bilirubin must be <50% of total bilirubin
- •For patients with Gilbert's syndrome: total bilirubin ≤3x ULN or direct bilirubin ≤1.5x ULN
- •Aspartate transaminase (AST) and alanine transaminase (ALT) ≤5x ULN
- •Alkaline Phosphatase <1.5x ULN
- •International Normalized Ratio (INR) ≤1.4
- •Model for End-Stage Liver Disease (MELD) score <12
- •Platelet count ≥110 000/mL
- •Albumin >3.4 g/dl
排除标准
- •Major surgery (major according to the investigator's assessment) performed within 24-weeks prior to randomization, major surgery planned within 6 months after screening (e.g. hip replacement), or bariatric surgery within 2 years prior to randomization
- •Any documented active or suspected malignancy or history of malignancy within 5-years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix. Specifically, any patients with suspected, confirmed, or history of hepatocellular carcinoma will be excluded
- •Suspected or confirmed portal vein thrombosis within 6 months of enrollment
- •History of liver transplantation
- •Current listing for liver transplantation
- •Present or past evidence of hepatic decompensation, in the opinion of the investigator, including but not limited to variceal hemorrhage, ascites, and/or hepatic encephalopathy
- •Patients with clinically significant portal hypertension defined by any one of the following:
- •FibroScan ≥25 Kilo Pascal (kPA) if the platelets are ≥150,000/μL
- •FibroScan ≥20 kPA if platelets are <150,000/μL
- •Evidence of esophageal or gastric varices (≥grade1) on the most recent endoscopy
- •Enhanced liver fibrosis (ELF) ≥11.3
- •Hepatic venous pressure gradient (HVPG) ≥10 mm Hg
- •further exclusion criteria apply
研究组 & 干预措施
Placebo for BI 770371
Placebo Comparator
干预措施: Placebo for BI 770371 (Drug)
BI 770371
Experimental
干预措施: BI 770371 (Drug)
结局指标
主要结局
Occurrence of treatment-emergent, drug-related adverse events in the BI 770371 and placebo arms
时间窗: Up to Week 15
次要结局
- Occurrence of adverse events (including clinically relevant findings from medical examination, safety laboratory tests, 12-lead ECG, vital signs, and assessment of local tolerability(Up to Week 22)
- Change from baseline in the fibrosis-related soluble biomarker PRO-C3 after 12 weeks of treatment(Baseline , at Week 12)
研究者
研究点 (25)
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