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NCT Number: NCT06778174

Prospective Analysis of the Treatment of Progressive Familial Intrahepatic Cholestasis (TreatFIC)

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Genetically confirmed cases of a PFIC type disease: FIC1 deficiency, BSEP deficiency, MDR3 deficiency, TJP2 deficiency, FXR deficiency, SLC51A deficiency, USP53 deficiency, KIF12 deficiency, ZFYE19 deficiency, MYO5B deficiency, SEMA7A deficiency, VPS33B deficiency, PSKH1 deficiency.

Exclusion criteria

  • Cases with suspected PFIC type disease, but without genetic testing data available.

Treatment and study plan

observational study

Other

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

Primary outcomes

  1. Number of participants with liver transplantation

    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

Secondary outcomes

  1. Number of participants that succumbed

    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

Other outcomes

  1. Number of participant undergoing a surgical biliary diversion

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Henkjan J Verkade, MD, PhD, Professor

CONTACT

[email protected]; [email protected]

31-50-3614147

Willem S Lexmond, MD, PhD

CONTACT

[email protected]

31-50-3614147

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: TreatFIC

Important dates

Study start
2023
Primary completion
2028
Study completion
2033
First posted
Jan 16, 2025
Registry last updated
Jan 24, 2025

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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