2023-509863-26-00招募中4 期
Stop of proton-pump inhibitor treatment in patients with liver cirrhosis – a doubleblind, placebo-controlled trial (STOPPIT)
University Medical Center Hamburg-Eppendorf19 个研究点 分布在 1 个国家目标入组 476 人开始时间: 2024年6月12日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 476
- 试验地点
- 19
- 主要终点
- Time to first unplanned re-hospitalization* or death within 12 months after randomization (composite endpoint). *Exception: expected re-hospitalization for paracentesis in patients with a history of refractory ascites (without any other complication of cirrhosis) during a period of 30 days.
研究概览
简要总结
To determine the time to first unplanned re-hospitalization or death (composite endpoint) in patients with liver cirrhosis who discontinue long-term proton-pump inhibitor (PPI) therapy (intervention group) as compared to patients who continue PPI therapy (control group) over a period of 12 months (360 days).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female adult (18 years) patient.
- •Provided written informed consent.
- •Liver cirrhosis (diagnosed either histologically or by a combination of clinical, laboratory and/or radiological signs).
- •Hospitalized or recently hospitalized (0 to 42 days before baseline) with complicated liver cirrhosis.
- •PPI treatment for at least 28 days prior to screening
- •PPI treatment with a single standard dose/day or less for a minimum of 7 days prior to screening.
- •Females/Males who agree to comply with the applicable contraceptive requirements of the protocol.
- •Non-pregnant, non-lactating females.
- •Ability to understand the patient information and to personally sign and date the informed consent to participate in the study, before completing any study related procedures.
- •The patient is co-operative and available for the entire study.
排除标准
- •Severe esophageal reflux disease (LA grade C or D) diagnosed by esophago-gastro-duodenoscopy (EGD) < 2 months prior to screening without PPI treatment for at least 8 weeks prior to screening.
- •Positive urine pregnancy test at screening or positive serum pregnancy test before the first treatment or is breast feeding.
- •Patient is not willing to use adequate contraceptive precautions during the study or for up to 5 days after the last scheduled dose of IMP.
- •Peptic ulcers diagnosed by EGD < 28 days prior to screening.
- •Endoscopic therapy for varices < 14 days prior to screening.
- •Life-expectancy < 1 year (at the discretion of the investigator) due to extrahepatic malignancies, metastasized hepatocellular carcinoma (HCC), or other severe extrahepatic-diseases. Importantly, HCC without extrahepatic metastases or a reduced life-expectancy < 1 year due to liver cirrhosis are not regarded as exclusion criteria.
- •Regular intake of non-steroidal anti-inflammatory drugs on a daily basis with the exemption of acetylsalicylic acid in a dosage of up to 100mg/day.
- •Patients with one or more of the following measurements at the time of screening or documented during 48 hours before screening: a. Body temperature > 38.5°C, or b. systolic blood pressure < 90 mmHg and tachycardia > 100 beats per minute, or c. ongoing catecholamine treatment higher than low dose norepinephrine ( 0.1 μg/kg/minute) (NB: terlipressin treatment for possible hepatorenal syndrome is not regarded as an exclusion criterion), or d. respiratory rate 22/minute.
- •Hypersensitivity or intolerance to esomeprazole, substituted benzimidazoles or other excipients of the investigational medicinal product (IMP; Nexium mups or Placebo).
- •Ongoing therapy with nelfinavir.
- •Participating in a clinical trial or use of an IMP within 30 days or five times the half-life of the IMP (whichever is longer) prior to receive the first dose within this study.
结局指标
主要结局
Time to first unplanned re-hospitalization* or death within 12 months after randomization (composite endpoint). *Exception: expected re-hospitalization for paracentesis in patients with a history of refractory ascites (without any other complication of cirrhosis) during a period of 30 days.
Time to first unplanned re-hospitalization* or death within 12 months after randomization (composite endpoint). *Exception: expected re-hospitalization for paracentesis in patients with a history of refractory ascites (without any other complication of cirrhosis) during a period of 30 days.
次要结局
- Death (all-cause and liver-related).
- Unplanned re-hospitalization.
- Any Infection and differentiated by site of infection (SBP, pneumonia, urinary tract infection, blood stream infection, Clostridium difficile-associated enterocolitis, Norovirus infection, Sars-CoV-2-infection).
- Acute hepatic decompensation and ACLF.
- Upper and lower gastrointestinal bleeding event.
- Experimental Endpoint: Changes of intestinal microbiota between baseline and day 90.
研究者
Ansgar Lohse
Scientific
University Medical Center Hamburg-Eppendorf
研究点 (19)
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