NCT05399745 BILACO Trial: Biliary Atresia - a Severe Complex Congenital Liver Disease
| NCT ID | NCT05399745 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Biliary Atresia |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-03-01 |
| Primary Completion | 2039-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2020-03-01 with a primary completion date of 2039-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Biliary atresia is the most severe form of cholestatic liver disease. The children have high morbidity and mortality and get devastating pruritus and fatigue, failure to thrive, progressive hepatic failure and impaired neurodevelopment. The etiology is mostly unknown. More than half need a new liver from a living or deceased donor during childhood. However, correct timing of the transplantation is extremely difficult because of lack of consensus based on clinical assessment tools. All though the incidence is low, the cost of this disease is tremendous from both a clinical and human perspective. So far, protocolized neurodevelopment tests, genetic profiling, precise malnutrition evaluation based on clinical appearance, biochemical markers and brain MRI-scans, body composition, immunological function, level of physical activity and optimal time of transplantation in cholestatic children are unknown. The aim is to determine risk factors for neurocognitive impairment in children suffering from severe cholestasis in order to determine optimal time for liver transplantation from a brain perspective. In a prospective study, the investigators will investigate risk factors related to brain-, heart-, gut- and immunological function in the Danish cohort. This cohort consists of 75 children aged 0-18 years. In addition, 30 aged and gender matched healthy and 20 tetra fallot children will serve as control groups. The children will undergo extensive and advanced liver function evaluation, genetic profiling, nutrition and immunological status, neuro-imaging and neurocognitive evaluation at time of diagnose, 2 years of age, pre-school, pre-teenage, and teenage. In case of a liver transplantation, additional neuro-cognitive tests will be performed
Eligibility Criteria
Inclusion Criteria: * Biliary atresia * Tetralogy of Fallot * Healthy controls Exclusion Criteria: \- Not able to participate in exams
Contact & Investigator
Vibeke Brix Christensen, MD, PhD, DMSc
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT05399745 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 18 Years, studying Biliary Atresia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05399745 currently recruiting?
Yes, NCT05399745 is actively recruiting participants. Contact the research team at vibeke.brix.christensen@regionh.dk for enrollment information.
Where is the NCT05399745 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT05399745 clinical trial?
NCT05399745 is sponsored by Rigshospitalet, Denmark. The principal investigator is Vibeke Brix Christensen, MD, PhD, DMSc at Rigshospitalet, Denmark. The trial plans to enroll 100 participants.