Better Diagnostic Tools for Children and Adolescents With Acute Liver Failure and Chronic Liver Insufficiency
DAKL
1 other identifier
observational
120
1 country
1
Brief Summary
The aim of this study is to validate and develop a new diagnostic and prognostic approach for assessment of liver function in children and adolescents with acute liver failure and chronic liver insufficiency. A carefully selected panel of functional and genomic tests along with diagnostic imaging and analysis of the microbiota will be performed in children and adolescents with acute liver failure and chronic liver insufficiency at Rigshospitalet. The tests will be performed in a serial manner in order to detect changes in outcomes. The study is an unblinded descriptive study, and approximately 20 patients with acute liver failure and 100 patients with chronic liver disease will be included in the project. This study will be the first of it's kind worldwide. The investigators expect the study to improve future diagnostic and prognostic accuracy and help the clinicians in identifying those patients in which the liver will regenerate itself, from those patients in which a liver transplantation will be lifesaving. Furthermore this study aims to help the clinicians in defining the optimal time for pediatric liver transplant in a narrow window of opportunity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2017
CompletedStudy Start
First participant enrolled
December 17, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2020
CompletedApril 26, 2018
April 1, 2018
3 years
December 11, 2017
April 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LTX free survival
in days
3 years
Secondary Outcomes (9)
HIDA
3 years
ICG
3 years
Cirrhosis
3 years
MR
3 years
fibroscan
3 years
- +4 more secondary outcomes
Study Arms (1)
Pediatric liver disease patients
Comparison of outcome of pediatric liver disease and prognostic functional liver test results and gene expression in liver biopsies.
Eligibility Criteria
All cause liver disease in pediatric patients.
You may qualify if:
- Children with Acute liver failure or children with Chronic Liver disease or Children with transplanted liver
You may not qualify if:
- Non stable patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of Pediatrics, Rigshospitalet
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, DmSc
Study Record Dates
First Submitted
December 11, 2017
First Posted
April 26, 2018
Study Start
December 17, 2017
Primary Completion
December 17, 2020
Study Completion
December 17, 2020
Last Updated
April 26, 2018
Record last verified: 2018-04