NCT06987968
终止
2 期
A Phase 2, Randomized, Controlled, Open-Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care Versus Standard of Care Alone in Patients With Overt Hepatic Encephalopathy
Genfit6 个研究点 分布在 3 个国家目标入组 3 人开始时间: 2025年8月25日最近更新:
概览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Genfit
- 入组人数
- 3
- 试验地点
- 6
- 主要终点
- Time to improvement of OHE as assessed by HEGI
概览
简要总结
A Phase 2, Randomized, Controlled, Open-Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care versus Standard of Care Alone in Patients with Overt Hepatic Encephalopathy
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
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with liver cirrhosis of any underlying etiology (liver cirrhosis diagnosed by standard clinical criteria, imaging findings and/or histology), who are diagnosed with Overt hepatic encephalopathy (OHE) (according to Hepatic Encephalopathy Grading Instrument) in the presence of:
- •Acute decompensation (AD)(defined as the onset or worsening of ascites, hepatic encephalopathy, gastrointestinal (GI) bleeding or any combination of them with or without infection); or
- •Acute on chronic liver failure (ACLF) grade 1 according to European Association for the Study of the Liver(EASL-CLIF) criteria; 2)Presence of ascites requiring diagnostic or therapeutic paracentesis; 3)Fasting blood ammonia \> upper limit of normal (ULN) at baseline (BL); 4)Patients with a dry body weight ≥40 kg and \<140 kg; 5)Male and female patients ≥18 to \<80 years of age on the day of signing the informed consent form (ICF); 6)Patients willing and able to provide written informed consent. If the patient is unable to fully understand or sign the written informed consent based on the Investigator's judgment, the ICF must be signed by a legal representative of the patient according to local regulation.
排除标准
- •ACLF grade 2 or higher as defined by European Association for the Study of the Liver-Chronic Liver Failure-Chronic Liver Failure (EASL-CLIF) criteria;
- •Presence of spontaneous or secondary bacterial peritonitis (i.e., neutrophil counts \>250/mm3 in ascitic fluid);
- •Contraindication for paracentesis according to the European Association for the Study of the Liver (EASL) Clinical Practice Guidelines 2018, and American Association for the Study of Liver Diseases (AASLD)Guideline on the Treatment of Ascites, Spontaneous Bacterial Peritonitis, and Hepatorenal Syndrome 2021;
- •Alfapump® in place to manage ascites;
- •Known hypersensitivity to liposomes, history of mastocytosis, multiple hypersensitivities or similar diseases known to be associated with an increased risk of allergic/anaphylactoid reactions;
- •Upper GI bleeding within the last 7 days prior to BL, acute bleeding or bleeding upon paracentesis at Screening (SCR) or Baseline (BL);
- •Poorly controlled seizure disorder;
- •Respiratory failure requiring invasive mechanical ventilation;
- •Severe circulatory failure requiring the use of high dose vasopressors (e.g., dopamine \>15 μg/kg/min, or epinephrine \>0.1 μg/kg/min, or norepinephrine \>0.1 μg/kg/min); the use of terlipressin or low-dose norepinephrine to treat hepatorenal syndrome is not an exclusion criterion;
- •Uncontrolled severe infection with hemodynamic instability or shock; patients may be enrolled provided anti-infectives have been administered for at least 48 hours prior to BL with an appropriate response as assessed by the Principal Investigator (PI);
研究组 & 干预措施
VS-01 with 3 hours Dwell time+ Standard of Care (SOC)
Experimental
Patients randomized to Active Treatment group will receive VS-01 3 hours Dwell time on top of SOC
干预措施: VS-01 on top of SOC (Active Treatment Group) (Drug)
VS-01 with 4 hours Dwell time+SOC
Experimental
Patients randomized to Active Treatment group will receive VS-01 4 hours Dwell time on top of SOC
干预措施: VS-01 on top of SOC (Active Treatment Group) (Drug)
SOC
Other
Patients randomized to Control group will receive SOC alone
干预措施: SOC (Drug)
结局指标
主要结局
Time to improvement of OHE as assessed by HEGI
时间窗: from randomization and up to Day 5 morning
次要结局
- The incidence and severity ([NCI CTCAE] v5.0 grade) of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), comprising the evaluation of vital signs, ECG parameters, and laboratory parameters(from randomization and up to Day 14 (more or less 3 days))
- Pharmacokinetics (PD) (for all arms): change from Baseline (BL) in fasting blood and peritoneal fluid ammonia levels.(from randomization up to Day 14 (more or less 3 days))
- Pharmacokinetics (PK) (for active treatment arms): blood and peritoneal fluid concentration-time profile of baseline (BL) corrected citric acid and lipids in patients treated with VS-01.(From randomization up to Day 5 or EOT (only for patients treated during 4 days))
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
Clinical Trial Enzyme Application Targeting Venous Leg UlcersVenous Leg UlcerLeg Injuries and DisordersNCT04956900SolasCure Limited43
撤回
2 期
Phase 2 Dose Finding sPIF in Patients With High Panel Reactive AntibodiesPanel Reactive AntibodiesNCT03593421Christopher O'Brien, MD
已完成
1 期
Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma (RCC)Renal Cell CarcinomaNCT03063762Hoffmann-La Roche69
招募中
1 期
Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate CancermCRPC (Metastatic Castration-resistant Prostate Cancer)Genital Diseases, MaleUrogenital Diseases, MaleProstatic DiseaseProstatic Neoplasms, Castration-ResistantProstate CancerNCT06190899Celcuity Inc54
已完成
2 期
Donated Antibodies Working Against nCoVCOVID-19NCT04429854Universitaire Ziekenhuizen KU Leuven483