2026-526044-12-00招募中4 期
Efficacy and safety of pharmacological therapy of obesity in liver transplant candidates
Institute For Clinical And Experimental Medicine1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2027年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Absolute and relative change in body weight/BMI/body fat composition during the follow-up period.
研究概览
简要总结
To evaluate the efficacy and safety of pharmacological obesity treatment (BMI ≥ 30) in liver transplant candidates.
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
- 否
入选标准
- •Liver transplant candidate undergoing pre-transplant evaluation (inpatient or outpatient) at the Department of Hepatogastroenterology, aged ≥18 years.
- •BMI ≥ 30, or BMI ≥ 33 in case of significant fluid retention (edema of lower extremities, ascites, hydrothorax; for large ascites/hydrothorax, BMI will be evaluated after evacuation puncture).
- •Clinically stable (patient is at home under outpatient follow-up or hospitalized on a standard ward without clinical or laboratory signs of significant deterioration or complications).
- •Signed informed consent.
排除标准
- •Hepatic encephalopathy
- •Refractory ascites/hydrothorax (≥2 evacuation procedures in the last 2 months).
- •Combined liver-kidney transplantation.
- •Pregnancy (pre-enrollment assessment includes a pregnancy test; women of childbearing potential must agree to use highly effective contraception — hormonal or barrier methods, or abstinence; highly effective methods are defined as those with failure rate <1% per year with correct and consistent use).
- •History of acute or chronic pancreatitis.
- •Polycystic liver disease
- •Type 1 diabetes mellitus
- •Liver malignancy outside Milan criteria (Milan-out, Klatskin tumor, colorectal carcinoma metastases, NET metastases).
- •Unstable clinical condition or unplanned hospitalization due to significant deterioration or complication.
- •Spontaneous weight loss (≥5% in the past 6 months, not due to diuretic or evacuation treatment).
- •Sarcopenia according to pre-transplant CT.
- •Inability to perform physical activity (walking 30 min/day).
结局指标
主要结局
Absolute and relative change in body weight/BMI/body fat composition during the follow-up period.
Absolute and relative change in body weight/BMI/body fat composition during the follow-up period.
次要结局
- Occurrence of complications while on the waiting list (WL) related to the underlying liver disease
- Safety of treatment (adverse events)
- Post-transplant complications (1M, 3M, 6M)
- Patient survival (1M, 3M, 6M)
- Graft survival (1M, 3M, 6M)
研究者
prof. MUDr. Tomáš Hucl, Ph.D.
Scientific
Institute For Clinical And Experimental Medicine
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Pharmacological Treatment - An Overview of Its Role in Managing Childhood ObesityNCT07304141Göteborg University128
招募中
Phase 3 4
Clinical trial on body fat loss in overweight subjectsCTRI/2025/01/079489Daehan chemtech co., Ltd.150
尚未招募
2/3 期
Study of intermittent fasting to check whether it can cause weight loss improve liver function and quality of life and normalise blood pressure in fatty liver patients when compared to those not following intermittent fastingCTRI/2024/02/062783Non funded study All India Institute of medical sciences jodhpur193
招募中
3 期
A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have CirrhosisCTRI/2025/01/079647Boehringer Ingelheim International GmbH1,590
招募中
1 期
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver FunctionNCT07269301Pfizer26