Menu
Recruiting NCT06767605

Spanish Registry of Autoimmune and Cholestatic Liver Diseases (ColHai)

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hepatitis Autoimmune Disease, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC), Cholestatic Genetic Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Registro Español de Enfermedades Hepáticas Colestásicas y Autoinmunes (ColHai)

Overview

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.

Primary outcome measures

  • Prevalence and characteristics of autoimmune and cholestatic liver disease in Spain [Time frame: 2025]
Secondary outcome measures (2)
  • Development of liver-related events in autoimmune ahd cholestatic liver diseases [Time frame: 2025]
  • Treatment of autoimmune and cholestatic liver diseases in Spain [Time frame: 2016-2030]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Hospital Clinic — Barcelona

Identifiers

NCT: NCT06767605 · HCB/2016/0565

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗