Spanish Registry of Autoimmune and Cholestatic Liver Diseases (ColHai)

Recruiting

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

• Registration Number: NCT06767605
• Lead Sponsor: Asociación Española para el Estudio del Hígado

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

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

Exclusion Criteria

• Refusal to sign the informed consent for the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence and characteristics of autoimmune and cholestatic liver disease in Spain	2025	Evaluation of clinical characteristics of autoimmune and cholestatic liver diseases

Secondary Outcome Measures

Name	Time	Method
Development of liver-related events in autoimmune ahd cholestatic liver diseases	2025
Treatment of autoimmune and cholestatic liver diseases in Spain	2016-2030

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain