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

Decompensated Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06344611
• Other study ID #: ILBS-DCLD-01
• Status: Not yet recruiting
• Start date: April 7, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Anmol Anmol, MD
• Phone: 01146300000
• Email: dranmol1991[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

Inclusion Criteria:

1. < 18 years of age at presentation

2. Decompensated cirrhosis at baseline

1. Cirrhosis:defined asliver histology findings (> F4 fibrosis as per Ishak system), and/or

2. radiological findings of an irregular nodular liver with/out left/caudate liver enlargement

3. Decompensation:defined as presence of ascites (any grade), and/orHE (overt), and/or variceal haemorrhage (endoscopy proven)

3. Fulfilling Recompensation criteria as per Baveno VII (2022) after treatment initiation

4. 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)

5. 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.

6. 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)

Exclusion Criteria:

1. refused consent

2. patients with liver cancer or other active malignancy

3. Any significant extrahepatic disease

Related Conditions & MeSH terms

• Decompensated Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the incidence of recompensation in pediatric subjects with decompensated cirrhosis as per Baveno VII criteria		1.5 years
Secondary	To evaluate the predictive factors of recompensation in pediatric DCLD subjects		1.5 years
Secondary	To investigate the systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in in pediatric subjects with decompensated cirrhosis.		1.5 years
Secondary	To assess incidence of re-decompensation in patients with recompensation.		2 years