Spanish Registry of Autoimmune and Cholestatic Liver Diseases (ColHai) (ColHai)

January 6, 2025 updated by: Asociación Española para el Estudio del Hígado

Registro Español de Enfermedades Hepáticas Colestásicas y Autoinmunes (ColHai)

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Asociación Española para el Estudio del Hígado Asociación Espa
  • Phone Number: 0034915551119
  • Email: registrocolhay@gmail.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence and characteristics of autoimmune and cholestatic liver disease in Spain
Time Frame: 2025
Evaluation of clinical characteristics of autoimmune and cholestatic liver diseases
2025

Secondary Outcome Measures

Outcome Measure
Time Frame
Development of liver-related events in autoimmune ahd cholestatic liver diseases
Time Frame: 2025
2025
Treatment of autoimmune and cholestatic liver diseases in Spain
Time Frame: 2016-2030
2016-2030

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación Española para el Estudio del Hígado

Investigators

  • Study Director: Maria Carlota Londoño Londoño, Asociación Española para el Estudio del Hígado

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2016/0565

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Sclerosing Cholangitis (PSC)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe