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RecruitingNCT06767605ColHaiUpdated Jan 10, 2025

Spanish Registry of Autoimmune and Cholestatic Liver Diseases (ColHai)

An observational study in Hepatitis Autoimmune Disease, Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC), sponsored by Asociación Española para el Estudio del Hígado. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-10.

Sponsored by Asociación Española para el Estudio del Hígado · Observational

From the registry’s dates

  • Started Jan 2016; still recruiting 10 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Liver Cirrhosis, Biliary

209 studies on the registry are indexed under Liver Cirrhosis, Biliary; 45 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 362 across 50 observational studies indexed under Liver Cirrhosis, Biliary.

Browse Liver Cirrhosis, Biliary studies →

Lead sponsor

Asociación Española para el Estudio del Hígado is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Refusal to sign the informed consent for the study
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
5,000 participants (estimated)
Target follow-up
35 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Prevalence and characteristics of autoimmune and cholestatic liver disease in Spain

    Evaluation of clinical characteristics of autoimmune and cholestatic liver diseases

    Time frame: 2025

Secondary outcomes

  1. Development of liver-related events in autoimmune ahd cholestatic liver diseases

    Time frame: 2025

  2. Treatment of autoimmune and cholestatic liver diseases in Spain

    Time frame: 2016-2030

07

Study locations

1 of 1 sites recruiting
  • Hospital Clinic
    Barcelona, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06767605
Lead sponsor
Asociación Española para el Estudio del Hígado
Responsible party
Sponsor
First posted
Jan 10, 2025
Start date
Jan 1, 2016
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Jan 10, 2025

Study contacts

Asociación Española para el Estudio del Hígado Asociación Espa
Contact
registrocolhay@gmail.com
0034915551119
Maria Carlota Londoño Londoño
study director · Asociación Española para el Estudio del Hígado

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Asociación Española para el Estudio del Hígado

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