Trial · NCT07889726
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival without further decompensation | 2 years | It will be defined as 1 large volume paracentesis \> 2 liters (one month after the randomization in case of ascites) or a new variceal bleeding or a new episode of overt hepatic encephalopathy (grade ≥ 2 of West-Heaven classification) or a new spontaneous bacterial peritonitis (neutrophils \> 250 / mm3 in ascites) or hepatorenal syndrome-acute kidney injury (according to the most recent definition) or jaundice (total bilirubin \> 50 μmol/l). It will be assessed during a 2-year follow-up period. |
| Secondary | Overall survival | 2 years | It will be assessed by measuring the overall survival, transplantation-free survival and liver-related death (composite criterion) during a 2-year follow up period. |
| Secondary | Incidence of new episode of grade 3 ascites | 1 month | It will be assessed by the apparition of new episode of grade 3 tense ascites defined as 1 large volume paracentesis \> 2 liters one month after the randomization. |
| Secondary | Number of large volume paracentesis (LVP) episodes per patient | 1 month | It will be assessed by the apparition of grade 3 tense ascites defined as 1 large volume paracentesis \> 2 liters one month after the randomization. |
| Secondary | Incidence of a new episode of variceal bleeding | 2 years | It will be assessed by the apparition of new episode of variceal bleeding according to Baveno V definition during a 2-year follow up period. |
| Secondary | Number of digestive bleeding episodes per patient | 2 years | It will be assessed by the apparition of new episode of variceal bleeding according to Baveno V definition during a 2-year follow up period. |
| Secondary | Incidence of a new episode of overt hepatic encephalopathy (Grade 2 - 4) | 2 years | It will be assessed by the apparition of new episode of overt hepatic encephalopathy defined as grade \> or = 2 according to the West-Haven classification during a 2-year follow up period. The West-Haven classification is a scale used to assess the severity of hepatic encephalopathy, consisting of 5 grades (0 corresponding to no clinical abnormalities and 4 to coma/unresponsive patient). |
| Secondary | Number of overt hepatic encephalopathy episodes per patient | 2 years | It will be assessed by the apparition of new episode of overt hepatic encephalopathy defined as grade \> or = 2 according to the West-Haven classification during a 2-year follow up period. |
| Secondary | Incidence of a new episode of severe overt hepatic encephalopathy (Grade 3 - 4) | 2 years | It will be assessed by the apparition of new episode of severe overt hepatic encephalopathy defined as grade \> or = 3 according to the West-Haven classification during a 2-year follow up period. |
| Secondary | Incidence of a new episode of jaundice | 2 years | It will be assessed by the apparition of new episode of jaundice defined as total bilirubin \> 50µmol/l during a 2-year follow up period. |
| Secondary | Incidence of new episode of spontaneous bacterial peritonitis (SBP) and hepatorenal syndrome-acute kidney injury (HRS-AKI) | 2 years | It will be assessed by the apparition of new episode of SBP and HRS-AKI (composite criterion) according to the most recent definition (Nadim et al, J Hepatol 2024) during a 2-year follow up period. |
| Secondary | Number of spontaneous bacterial peritonitis (SBP) and hepatorenal syndrome-acute kidney injury (HRS-AKI) episodes per patient | 2 years | It will be assessed by the apparition of new episode of SBP and HRS-AKI (composite criterion) according to the most recent definition (Nadim et al, J Hepatol 2024) during a 2-year follow up period. |
| Secondary | Number of acute on chronic liver failure episodes per patient | 2 years | It will be assessed by the apparition of new episode of acute on chronic liver failure defined according to EASL-CLIF consortium during a 2-year follow up period. |
| Secondary | Number of re-hospitalizations per patient | 2 years | It will be assessed by the number of re-hospitalizations during a 2-year follow up period. |
| Secondary | Number of days spent in hospitalization | 2 years | It will be assessed by the number of days spent in hospitalization during a 2-year follow up period. |
| Secondary | Safety throughout the course of the study | 2 years | It will be assessed by all the adverse events collected during a 2-year follow up period. |
| Secondary | Incidence of a new episode of Acute on Chronic Liver Failure | 2 years | It will be assessed by the apparitionof new epidose of acute chronic liver failure defined according to EASL-CLIF consortium during a 2 years follow-up period |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07889726/registered