Incidence & Predictive Factors of Recompensation in Children With Decompensated Cirrhosis as Per the Baveno VII Criteria

NCT06344611 | Not Yet Recruiting

• 1 other identifier: ILBS-DCLD-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• To determine the incidence of recompensation in pediatric subjects with decompensated cirrhosis as per Baveno VII criteria

  1.5 years

Secondary Outcomes (3)

• To evaluate the predictive factors of recompensation in pediatric DCLD subjects

  1.5 years

• To investigate the systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in in pediatric subjects with decompensated cirrhosis.

  1.5 years

• To assess incidence of re-decompensation in patients with recompensation.

  2 years

Study Arms (1)

Decompensated Cirrhosis

Other: Other

Interventions

Other OTHER

It is an observational study. Subjects will receive the treatment as per institute protocol.

Decompensated Cirrhosis

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects visiting to ILBS with decompensated Chronic liver disease from Aug 2023 till April 2025.

You may qualify if:

• \< 18 years of age at presentation
• Decompensated cirrhosis at baseline
• Cirrhosis:defined asliver histology findings (\> F4 fibrosis as per Ishak system), and/or
• radiological findings of an irregular nodular liver with/out left/caudate liver enlargement
• Decompensation:defined as presence of ascites (any grade), and/orHE (overt), and/or variceal haemorrhage (endoscopy proven)
• Fulfilling Recompensation criteria as per Baveno VII (2022) after treatment initiation
• Sustained cure, suppression or removal of the underlying aetiology of cirrhosis
• a. Includes treatable etiologies like Hepatitis B, Autoimmune liver disease, Wilson disease, Budd Chiari syndrome, MLDs (like Galactosemia, Tyrosinemia, Bile acid synthetic defects)
• Resolution of ascites and hepatic encephalopathy (HE) after discontinuation of diuretics and prophylactic therapies, as well as the absence of variceal bleeding for 12 months.
• Sustained improvement of biochemical liver function, as as- sessed by serum albumin, bilirubin and INR (international normalized ratio) a. improvement in liver function parameters to values within normal ranges (albumin \>35 g/L \& INR \< 1.5 \& bilirubin \< 2 mg/dl)

You may not qualify if:

• refused consent
• patients with liver cancer or other active malignancy
• Any significant extrahepatic disease

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Central Study Contacts

Dr Anmol Anmol, MD

CONTACT

01146300000; dranmol1991@gmail.com

Dr Vikrant Sood, DM

CONTACT

011-46300000; drvickyster@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: April 7, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-03

Locations

IN (1)