CTIS2022-502899-23-00进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RIFAXIMIN SOLUBLE SOLID DISPERSION (SSD) TABLETS FOR THE DELAY OF ENCEPHALOPATHY DECOMPENSATION IN CIRRHOSIS (RED-C) - RNLC3132
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 424
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •A participant will be eligible for inclusion in this study if he/she meets all of the following criteria: 1. Participant has a diagnosis of liver cirrhosis with medically controlled ascites (> 30 days). Cirrhosis diagnosis can be made using any of the following: o Histopathological evidence of cirrhosis o Magnetic resonance imaging (MRI) o Computed tomography (CT) o Fibroscan (Transient Elastography) o Imaging (sonographic or cross-sectional) o Presence of esophageal varices o Thrombocytopenia (<150,000/µL) in participants with CLD Medically controlled ascites (>30 days) includes: o Ascites that is controlled by diet and/or medication for over 30 days and that does not require recurring therapeutic paracentesis (could have had paracentesis in the past)., Participant has a Conn (West Haven Criteria [WHC]) score of < 2., Participant has a Mini-Mental State Examination (MMSE) score > 24 at screening., Participant is = 18 and = 85 years of age., Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening. All participants must agree to use highly effective methods of contraception throughout their participation in the study., Participant must be able to independently read, fully understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form (ICF) without additional support and provide authorization as appropriate per local privacy regulations.
排除标准
- •Participant has an active COVID-19 infection that is unresolved or, in the opinion of the investigator, may affect evaluation of the study drug or might place the subject at undue risk., Participant has a history of substance abuse < 6 months prior to signing the ICF and cannot refrain from substance abuse during the study period. For alcohol abuse, participants undergoing alcohol use counselling or receiving Alcohol Use Disorder pharmacotherapy, can be considered for inclusion., Participants on antipsychotic medications should be excluded irrespective of indication or dose. Participants who discontinue psychoactive medications with a washout period of 30 days before providing consent are allowed. Benzodiazepine, psychoactive medicine, and opioid use are excluded, with the exception of: a. Participants on stable dose psychoactive medicines may be included. b. Participants are allowed to remain on opioids, if on a stable opioid dose for at least 30 days., Participant has been diagnosed with an uncontrolled infection < 4 weeks prior to screening., Participant has been diagnosed with an upper gastrointestinal bleed from non-variceal sources < 6 weeks prior to screening., Participant shows presence of intestinal obstruction or has inflammatory bowel disease., Participant has undergone bariatric surgery or intestinal resection. Limited segmental resection of colon (e.g., adenomatous polyp) > 2 years prior is allowed., Participant has a history of an acute portal vein thrombosis that requires anticoagulants within the past 3 months, a history of a TIPS procedure, or plans to undergo a TIPS procedure., Participant has a history of shunt surgery or direct intrahepatic portocaval shunt (DIPS) procedure for portal hypertension or plans to undergo a DIPS procedure., Participant requires peritoneal dialysis or hemodialysis., Participant has undergone prophylactic variceal banding within 2 weeks of screening (Note: participants with previous prophylactic variceal banding will be allowed to participate in the study)., Participant has a history of anaphylaxis or hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any of the components of rifaximin., Participant has Type 1 or Type 2 diabetes that is not adequately controlled in the opinion of the investigator., Participant with a life expectancy < 18 months., Participant has active malignancy (except basal carcinoma of the skin), including active hepatocellular carcinoma (HCC). Participants with resections or ablations of squamous cell carcinoma of the skin, or in situ carcinoma of the cervix, that occurred greater than 6 months prior to screening and are considered disease free are eligible for enrollment., Evidence of HCC or a probable HCC lesion within 6 months on ultrasound or contrast multiphase MRI or CT. If there is a lesion suspicious for HCC and this imaging is not available, or if alpha-fetoprotein (AFP) is = 20 ng/mL at screening, participants should undergo standard of care diagnostic procedures with their physician to rule out HCC during the screening period., Participant has any condition or circumstance that adversely affects the participant, could cause noncompliance with treatment or visits, may impact the interpretation of clinical data, could cause bias, or may otherwise contraindicate the participant’s participation in the study., Participant used any investigational product or device within 30 days or 5 half-lives of the investigational product (whichever co
研究者
相似试验
已完成
不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, COMPARATIVE, SAFETY AND EFFICACY STUDY OF INTRAVENOUS ZOLEDRONATE (4 AND 8 MG) IN PROSTATE CANCER PATIENTS WITH METASTATIC BONE LESIONS RACEIVING ANTINEOPLASTIC THERAPYPER-011-99OVARTIS BIOSCIENSES PERÚ S.A.,
进行中（未招募）
1 期
A blind (not knowing which treatment to receive), placebo-controlled (with chance to receive sugar pill) study to evaluate whether brivaracetam can be used treating partial onset seizures in patients with epilepsy (= 16 to 80 years old)EUCTR2010-019361-28-ROCB BIOSCIENCES, INC.768
进行中（未招募）
不适用
A blind (not knowing which treatment to receive), placebo-controlled (with chance to receive sugar pill) study to evaluate whether brivaracetam can be used treating partial onset seizures in patients with epilepsy (= 16 to 80 years old)EUCTR2010-019361-28-LVCB BIOSCIENCES, INC.900
进行中（未招募）
1 期
MP1032 Treatment in Patients with Moderate to Severe COVID-19EUCTR2021-000344-21-ITMetrioPharm AG120
进行中（未招募）
不适用
A blind (not knowing which treatment to receive), placebo-controlled (with chance to receive sugar pill) study to evaluate whether brivaracetam can be used treating partial onset seizures in patients with epilepsy (= 16 to 80 years old)EUCTR2010-019361-28-DECB BIOSCIENCES, INC. A Member of the UCB Group of Companies900