Actively 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
Led by Ipsen · Updated on 2026-04-30
150
Participants Needed
10
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older who provide written informed consent before data collection and study procedures
- Unexplained recurrent and/or chronic cholestasis, defined by elevated alkaline phosphatase (ALP) or Gamma-Glutamyl Transferase (GGT) above normal limits
- Patients willing to provide a blood sample for genetic analysis
You will not qualify if you...
- Patients with confirmed causes of cholestasis such as Primary Biliary Cholangitis or Primary/Secondary Sclerosing Cholangitis
- Patients with bile duct obstruction
- Patients with other liver diseases including cholestasis due to hepatocellular injury, viral hepatitis (Hepatitis A, B, or C), toxic or drug-induced hepatitis, or autoimmune hepatitis
- Patients with intestinal failure or on total parenteral nutrition
- Patients with Wilson's disease, choledochal cyst, Caroli Syndrome, or thick bile due to haemolysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
H. Clinic (first CEIm)
Barcelona, Spain
Actively Recruiting
2
H. Vall Hebron
Barcelona, Spain
Not Yet Recruiting
3
H. Reina Sofía
Córdoba, Spain
Not Yet Recruiting
4
H. Dr. Negrín
Las Palmas, Spain
Not Yet Recruiting
5
H. Gregorio Marañón
Madrid, Spain
Not Yet Recruiting
6
Hospital Universitario La Paz
Madrid, Spain
Not Yet Recruiting
7
H. Virgen del Rocío
Seville, Spain
Not Yet Recruiting
8
H. La Fe
Valencia, Spain
Not Yet Recruiting
9
H. Río Hortega
Valladolid, Spain
Actively Recruiting
10
H. Miguel Servet
Zaragoza, Spain
Actively Recruiting
Research Team
I
Ipsen Clinical Study Enquiries
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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