NCT07191704 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
| NCT ID | NCT07191704 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ipsen |
| Condition | PFIC - Progressive Familial Intrahepatic Cholestasis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2026-07-31 |
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 150 participants in total. It began in 2025-12-08 with a primary completion date of 2026-07-31.
⚠ 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
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 genetic testing for patients with unexplained bile issues-after ruling out more common causes-to better understand the problem. However, there isn't much information on how common these genetic changes are in adults with these liver issues, especially in Spain. This study will observe these genetic changes so that doctors can diagnose the condition more clearly and create personalized treatment plans. This study will be conducted in several centers across Spain for 10 months. Each adult participant will take part in a single-day visit where their health information will be collected, and a blood sample will be taken for both routine tests and genetic analysis.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Ipsen Medical Director
STUDY DIRECTOR
Ipsen
Frequently Asked Questions
Who can join the NCT07191704 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PFIC - Progressive Familial Intrahepatic Cholestasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07191704 currently recruiting?
Yes, NCT07191704 is actively recruiting participants. Contact the research team at clinical.trials@ipsen.com for enrollment information.
Where is the NCT07191704 trial being conducted?
This trial is being conducted at Barcelona, Spain, Barcelona, Spain, Córdoba, Spain, Las Palmas, Spain and 6 additional locations.
Who is sponsoring the NCT07191704 clinical trial?
NCT07191704 is sponsored by Ipsen. The principal investigator is Ipsen Medical Director at Ipsen. The trial plans to enroll 150 participants.