Status:
RECRUITING
A Study to Assess the Genetic Variations in Bile Flow Disorders: Linking Progressive Familial Intrahepatic Cholestasis (PFIC)-Related Genes to Symptoms in Adults With Recurrent Cholestasis in Spain
Lead Sponsor:
Ipsen
Conditions:
PFIC - Progressive Familial Intrahepatic Cholestasis
Eligibility:
All Genders
18+ years
Brief Summary
Progressive Familial Intrahepatic Cholestasis (PFIC) is a group of inherited conditions that affect how bile moves in the liver, which can lead to serious liver problems. Doctors usually recommend gen...
Eligibility Criteria
Inclusion
- Adult patients (≥18 years old) with written informed consent prior to data collection and study procedures.
- Unexplained recurrent and/or chronic cholestasis (idiopathic cholestasis), defined as alkaline phosphatase (ALP) or Gamma-Glutamyl Transferase (GGT) \> Upper Limit of Normal (ULN).
- Patients who provide the blood sample for the genetic analysis.
Exclusion
- Patients with clear and confirmed diagnosed causes of cholestasis, including:
- Primary Biliary Cholangitis
- Primary or Secondary Sclerosing Cholangitis
- Obstruction of the bile ducts
- Other Liver diseases: cholestasis secondary to hepatocellular injury, viral hepatitis (mainly Hepatitis A virus \[HAV\], Hepatitis B virus \[HBV\] and Hepatitis C virus \[HCV\]), toxic hepatitis (pharmacological; drug-induced liver injury \[DILI\]), autoimmune hepatitis; intestinal failure, total parenteral nutrition \[TPN\]; Wilson's disease, choledochal cyst, Caroli Syndrome, and thick bile due to haemolysis.
Key Trial Info
Start Date :
December 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07191704
Start Date
December 8 2025
End Date
July 31 2026
Last Update
January 5 2026
Active Locations (10)
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1
H. Clinic (first CEIm)
Barcelona, Spain
2
H. Vall Hebron
Barcelona, Spain
3
H. Reina Sofía
Córdoba, Spain
4
H. Dr. Negrín
Las Palmas, Spain