Spanish Registry of Autoimmune and Cholestatic Liver Diseases (ColHai)
Observational · No treatment assigned · 1 site · Asociación Española para el Estudio del Hígado
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Hepatitis Autoimmune Disease, Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Patients with a confirmed diagnosis for PBC, HAI, PSC, genetic cholestatic disease
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 5000 participants are expected to take part.
- Start date: 2016-01-01.
- Main results expected around 2030-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Spain.
Main thing being measured
- Prevalence and characteristics of autoimmune and cholestatic liver disease in Spain (2025)
In the researchers’ words
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.
Words you might see
- Cholestasis: reduced or blocked flow of bile.
- PBC: primary biliary cholangitis, a different chronic bile-duct disease.
- Autoimmune hepatitis: a liver disease where the immune system attacks the liver.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Hepatitis Autoimmune Disease; Primary Biliary Cholangitis (PBC); Primary Sclerosing Cholangitis (PSC); Cholestatic Genetic Diseases |
| Lead sponsor | Asociación Española para el Estudio del Hígado |
| Enrollment | 5000 (estimated) |
| Start date | 2016-01-01 |
| Primary completion (est.) | 2030-12 |
| First posted | 2025-01-10 |
| Last updated | 2025-01-10 |
| Official title | Registro Español de Enfermedades Hepáticas Colestásicas y Autoinmunes (ColHai) |
| ClinicalTrials.gov ID | NCT06767605 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic | Barcelona | Spain | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.