Clinical Trials Logo

Clinical Trial Summary

Cirrhosis is a leading cause of morbidity and mortality world- wide and can develop on the basis of repetitive and/or chronic liver injury due to toxic, infectious, metabolic and genetic pathogenic factors. Traditionally, the natural history of cirrhosis has often been considered a one-way street, with a definite and irreversible progression from a compensated to a decompensated disease stage. But recent data has shown that if the underlying etiology can be successfully treated, cirrhosis can regress and recompensation of liver disease can occur. Hence, in this study we want to evaluate the incidence and predictive factors of recompensation in pediatric subjects with decompensated cirrhosis as per the Baveno VII criteria. We would also evaluate the predictive factors of recompensation in pediatric decompensated chronic liver disase (DCLD) subjects and would explore systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in pediatric subjects with decompensated cirrhosis.


Clinical Trial Description

Aim- To evaluate the incidence and predictive factors of recompensation in pediatric subjects with decompensated cirrhosis as per the Baveno VII criteria Primary objective: To determine the incidence of recompensation in pediatric subjects with decompensated cirrhosis as per Baveno VII criteria Secondary objectives: 1. To evaluate the predictive factors of recompensation in pediatric DCLD subjects 2. To investigate the systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in pediatric subjects with decompensated cirrhosis 3. To assess incidence of re-decompensation in patients with recompensation Study design: Prospective, Observational study. Study period:2 years (Aug 2023-Jul2025). Sample size: Time bound; All decompensated cirrhosis cases presenting to the institute during the study period will be included in the study. Intervention: None, since it is an observational study only - Monitoring and assessment: - Along with standard tratment plan/investigatios (as per etiology), Liver function test, INR and Ultrasound abdomen would be done at 3 monthly interval. - At baseline: Markers of Systemic Inflammation (serum levels of IL-6, TNFα, IL-1β; Monocyte/Basophil Frequency, NLR; CRP, Procalcitonin) and Intestinal Inflammation (Stool cytokines- IL-6, TNFα, IL-1β, IL-10) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06344611
Study type Observational
Source Institute of Liver and Biliary Sciences, India
Contact Dr Anmol Anmol, MD
Phone 01146300000
Email dranmol1991@gmail.com
Status Not yet recruiting
Phase
Start date April 7, 2024
Completion date March 31, 2026

See also
  Status Clinical Trial Phase
Completed NCT01701687 - Biomarkers for the Prognosis of Decompensated Alcoholic Liver Disease N/A
Recruiting NCT05121870 - Treatment With Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis Phase 2
Recruiting NCT05421351 - Immune Profile, Neuronal Dysfunction, Metabolomics and Ammonia in Therapeutic Response of HE in ACLF
Not yet recruiting NCT05086536 - Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis
Recruiting NCT03820271 - New Prognostic Predictive Models of Mortality of Decompensated Cirrhotic Patients Waiting for Liver Transplantation N/A
Recruiting NCT06134544 - Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis N/A
Recruiting NCT06223893 - CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis N/A
Completed NCT02219477 - A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis Phase 3
Recruiting NCT05734001 - Rotational Thromboelastometry Versus Conventional Haemostatic Tests in Children With Decompensated Cirrhosis Undergoing Invasive Procedures. N/A
Terminated NCT04775329 - Primary Prophylaxis for Spontaneous Bacterial Peritonitis Phase 2/Phase 3
Recruiting NCT04422223 - Prospective Cohort Study of Disease and Outcomes in Cirrhosis
Recruiting NCT02786017 - Injectable Collagen Scaffold™ Combined With HUC-MSCs Transplantation for Patients With Decompensated Cirrhosis Phase 1/Phase 2
Completed NCT01326949 - Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis N/A
Not yet recruiting NCT06306781 - A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HCL001 Cell Injection (Homologous Allogeneic Hepatocytes) in Patients With Decompensated Cirrhosis N/A
Recruiting NCT05227846 - Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-1) Phase 1
Not yet recruiting NCT05937048 - Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D). N/A
Active, not recruiting NCT03205345 - Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis Phase 2
Terminated NCT03462576 - Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17
Terminated NCT04112199 - A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites Phase 2
Not yet recruiting NCT06396897 - Hospital @ Home Model of Care for Cirrhosis