Hepatitis Autoimmune DiseaseColHaiNCT06767605
Spanish Registry of Autoimmune and Cholestatic Liver Diseases (ColHai)
An observational study of Hepatitis Autoimmune Disease and Primary Biliary Cholangitis (PBC), run by Asociación Española para el Estudio del Hígado at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis Autoimmune Disease, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC)
- How many people
- 5,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2016to Dec 2030
- How long will I take part?
- 35 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a confirmed diagnosis for PBC, HAI, PSC or any genetic cholestasis
Who may be able to join
- Patients with a confirmed diagnosis for PBC, HAI, PSC, genetic cholestatic disease
Who cannot join
- Refusal to sign the informed consent for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Asociación Española para el Estudio del Hígado Asociación Espa contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona
Maria Carlota Londoño Londoño, mlONDONO@clinic.cat
About this study
Official title: 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.
- Conditions
- 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
- Medical subject headings
- Liver Cirrhosis, Biliary, Cholangitis, Sclerosing, Alagille Syndrome, Hyperbilirubinemia, Hereditary, Jaundice, Chronic Idiopathic, Genetic Diseases, Inborn
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and characteristics of autoimmune and cholestatic liver disease in Spain
Evaluation of clinical characteristics of autoimmune and cholestatic liver diseases
Measured: 2025
Secondary outcomes (2)
Development of liver-related events in autoimmune ahd cholestatic liver diseases
Measured: 2025
Treatment of autoimmune and cholestatic liver diseases in Spain
Measured: 2016-2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jan 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis Autoimmune DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 35 Years
Sponsor and investigators
- Lead sponsor
- Asociación Española para el Estudio del Hígado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Carlota Londoño Londoño, Study director, Asociación Española para el Estudio del Hígado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767605
- Sponsor's protocol ID
- HCB/2016/0565
- Acronym
- ColHai
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registro Español de Enfermedades Hepáticas Colestásicas y Autoinmunes (ColHai)
- ClinicalTrials.gov ID
- NCT06767605
- Acronym / sponsor ID
- ColHai / HCB/2016/0565
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Asociación Española para el Estudio del HígadoUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 35 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a confirmed diagnosis for PBC, HAI, PSC or any genetic cholestasis
Key inclusion criteria (1 listed)
- Patients with a confirmed diagnosis for PBC, HAI, PSC, genetic cholestatic disease
Key exclusion criteria (1 listed)
- Refusal to sign the informed consent for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and characteristics of autoimmune and cholestatic liver disease in Spain
Time frame: 2025
Evaluation of clinical characteristics of autoimmune and cholestatic liver diseases
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asociación Española para el Estudio del Hígado Asociación Espa contact
Maria Carlota Londoño Londoño study director
Asociación Española para el Estudio del Hígado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis Autoimmune Disease and Primary Biliary Cholangitis (PBC), run by Asociación Española para el Estudio del Hígado at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asociación Española para el Estudio del Hígado Asociación Espa (0034915551119, registrocolhay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and characteristics of autoimmune and cholestatic liver disease in Spain (time frame: 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.