University Medical Center Groningen
Groningen, 9700 RB, Netherlands
Location status: Recruiting
Location contact
Henkjan J Verkade, MD, PhD, Professor
CONTACT
[email protected]; [email protected]
Willem S Lexmond, MD, PhD
CONTACT
NCT Number: NCT06778174
The project has the following general aims:
1. Natural course and prognosis: To prospectively follow the natural course and prognosis of the different types of PFIC, to broaden the understanding of the different very rare diseases and to allow predictions about the course of disease in different types of PFIC. 2. Efficacy: To define the course of disease in FIC patients and identify associations with different treatments (symptomatic treatments, interruption of the enterohepatic circulation by surgical or medical means and other therapies such as corrector/potentiator or exon skipping therapy. The course of disease will be characterized by biochemical, clinical and surgical parameters, including liver transplantation. 3. Safety: To define the complications associated with the different treatments (symptomatic treatments, interruption of the enterohepatic circulation by surgical or medical means and other therapies such as corrector/potentiator or exon skipping therapy, liver transplantation). Follow up will be as long as possible. 4. (Surrogate) biomarker response: Biochemical parameters will be longitudinally collected and associated with changes in treatments / course of disease. 5. Genotype-phenotype relationships: If patient numbers permit, to establish genotype-phenotype relationships for (non)responsiveness towards different treatments in patients with genetic mutations causing the different forms of FIC disease.
Interested in participating?
Request InfoAll sexes
Observational
Groningen, 9700 RB, Netherlands
Location status: Recruiting
Henkjan J Verkade, MD, PhD, Professor
CONTACT
[email protected]; [email protected]
Willem S Lexmond, MD, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The interventions are not determined by the study, which is purely observational on "real world data".
Other names: natural history, surgical biliary diversion, liver transplantation, IBAT-inhibition
Time frame: at 5, 10, 15 and 18 years of age, as well as >18 years of age
The number (percentage) of patients undergoing liver transplantation related to the age of the patient
Time frame: at 5, 10, 15 and 18 years of age, as well as >18 years of age
Mortality related to age of the patient
Time frame: at 5, 10, 15 and 18 years of age, as well as >18 years of age
Number of participant undergoing a surgical biliary diversion related to age
Contact information is provided by the study sponsor or research team.
Henkjan J Verkade, MD, PhD, Professor
CONTACT
[email protected]; [email protected]
Willem S Lexmond, MD, PhD
CONTACT
University Medical Center Groningen
Other
Acronym: TreatFIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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