Spanish Registry of Autoimmune and Cholestatic Liver Diseases (ColHai)

NCT06767605 | Recruiting DMC

• 1 other identifier: HCB/2016/0565
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the registry is to know the status of primary biliary colgantis, autoimmune hepatitis, primary sclerosing cholagitis and genetic cholestatic diseases in Spain.

Conditions

Hepatitis Autoimmune Disease; Primary Biliary Cholangitis (PBC); Primary Sclerosing Cholangitis (PSC); Cholestatic Genetic Diseases

Keywords

Cholestatic Genetic Diseases; Primary Sclerosing Cholangitis (PSC); Hepatitis Autoimmune Disease; Primary Biliary Cholangitis (PBC); PFIC tipo 1; PFIC tipo 2; PFIC tipo 3; PFIC tipo 4; BRIC tipo 1; BRIC tipo 2; Alagille syndrome; Rotor syndrome; Dubin Johnson syndrome; Genetic disease; Registry; cholestatic diseases

Outcome Measures

Primary Outcomes (1)

• Prevalence and characteristics of autoimmune and cholestatic liver disease in Spain

  Evaluation of clinical characteristics of autoimmune and cholestatic liver diseases

  2025

Secondary Outcomes (2)

• Development of liver-related events in autoimmune ahd cholestatic liver diseases

  2025

• Treatment of autoimmune and cholestatic liver diseases in Spain

  2016-2030

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a confirmed diagnosis for PBC, HAI, PSC or any genetic cholestasis

You may qualify if:

• Patients with a confirmed diagnosis for PBC, HAI, PSC, genetic cholestatic disease

You may not qualify if:

• Refusal to sign the informed consent for the study

Sponsors & Collaborators

• Asociación Española para el Estudio del Hígado: lead

Study Sites (1)

Hospital Clinic

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Cholangitis, Sclerosing; Alagille Syndrome; Hyperbilirubinemia, Hereditary; Jaundice, Chronic Idiopathic; Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cholangitis; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Jaundice, Neonatal; Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Chronic Disease; Disease Attributes

Study Officials

• Maria Carlota Londoño Londoño

  Asociación Española para el Estudio del Hígado

  STUDY DIRECTOR

Central Study Contacts

Asociación Española para el Estudio del Hígado Asociación Espa

CONTACT

0034915551119; registrocolhay@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 35 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)