Cirrhosis, LiverNCT04199910
4beta-hydroxycholesterol in Cirrhosis
An observational study of Cirrhosis, Liver, run by University of Oulu at 1 site in Finland.
Trial summary
The aim is to evaluate the levels of oxysterols and especially 4beta-hydroxycholesterol in patients with liver cirrhosis. Three cirrhosis cohorts are recruited: patients treated with spironolactone, patients treated with rifaximin, patients without spironolactone or rifaximin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 1 Dec 2019to 31 Dec 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
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 cirrhosis, pneumonia, Crohn's disease or colitis ulcerosa treated in the ward 42 of the Oulu University Hospital
Who may be able to join
- Patients with cirrhosis, pneumonia, Crohn's disease or colitis ulcerosa
- Treated in the ward 42 of the Oulu University Hospital
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 4beta-hydroksikolesteroli Maksakirroosissa
The aim is to evaluate the levels of oxysterols and especially 4beta-hydroxycholesterol in patients with liver cirrhosis. Three cirrhosis cohorts are recruited: patients treated with spironolactone, patients treated with rifaximin, patients without spironolactone or rifaximin. Also three other control cohorts are recruited: patients with pneumonia, patients with Crohn's disease, patients with ulcerative colitis. The effect of the cirrhosis and its medications spironolactone and rifaximin are compared to control groups.
- Conditions
- Cirrhosis, Liver
- Being tested
- There is no intervention, only research blood samples are collected
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention, only research blood samples are collectedOther
Research blood samples collected
| Study group | Role | What they receive |
|---|---|---|
| Liver cirrhosis with spironolactone | Not described Receives: Other: There is no intervention, only research blood samples are collected | |
| Liver cirrhosis with rifaximin | Not described Receives: Other: There is no intervention, only research blood samples are collected | |
| Liver cirrhosis without spironolactone or rifaximin | Not described Receives: Other: There is no intervention, only research blood samples are collected | |
| Pneumonia | Not described Receives: Other: There is no intervention, only research blood samples are collected | |
| Crohn's disease | Not described Receives: Other: There is no intervention, only research blood samples are collected | |
| Ulcerative colitis | Not described Receives: Other: There is no intervention, only research blood samples are collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood 4beta-hydroxycholesterol concentration
Blood 4beta-hydroxycholesterol concentration
Measured: At the time point of the blood collection - cross-sectional. One day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start1 Dec 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: COVID pandemia and organisational changes hinder recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janne Hukkanen, University of Oulu
- Investigators
- Janne Hukkanen, MD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199910
- Sponsor's protocol ID
- 4bHC kirroosissa
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2019
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4beta-hydroksikolesteroli Maksakirroosissa
- ClinicalTrials.gov ID
- NCT04199910
- Acronym / sponsor ID
- 4bHC kirroosissa
- Conditions
- Cirrhosis, Liver
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID pandemia and organisational changes hinder recruitment
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Dec 2019 (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 aim is to evaluate the levels of oxysterols and especially 4beta-hydroxycholesterol in patients with liver cirrhosis. Three cirrhosis cohorts are recruited: patients treated with spironolactone, patients treated with rifaximin, patients without spironolactone or rifaximin. Also three other control cohorts are recruited: patients with pneumonia, patients with Crohn's disease, patients with ulcerative colitis. The effect of the cirrhosis and its medications spironolactone and rifaximin are compared to control groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Liver cirrhosis with spironolactone | – | Other: There is no intervention, only research blood samples are collected |
| Liver cirrhosis with rifaximin | – | Other: There is no intervention, only research blood samples are collected |
| Liver cirrhosis without spironolactone or rifaximin | – | Other: There is no intervention, only research blood samples are collected |
| Pneumonia | – | Other: There is no intervention, only research blood samples are collected |
| Crohn's disease | – | Other: There is no intervention, only research blood samples are collected |
| Ulcerative colitis | – | Other: There is no intervention, only research blood samples are collected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cirrhosis, pneumonia, Crohn's disease or colitis ulcerosa treated in the ward 42 of the Oulu University Hospital
Key inclusion criteria (2 listed)
- Patients with cirrhosis, pneumonia, Crohn's disease or colitis ulcerosa
- Treated in the ward 42 of the Oulu University Hospital
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention, only research blood samples are collectedResearch blood samples collected | Other | Crohn's disease, Liver cirrhosis with rifaximin, Liver cirrhosis with spironolactone, Liver cirrhosis without spironolactone or rifaximin, Pneumonia, Ulcerative colitis |
Primary outcome
Blood 4beta-hydroxycholesterol concentration
Time frame: At the time point of the blood collection - cross-sectional. One day.
Blood 4beta-hydroxycholesterol concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Janne Hukkanen, MD principal investigator
Oulu University Hospital
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 Cirrhosis, Liver, run by University of Oulu at 1 site in Finland.
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 2 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: paused, as of the sponsor's last update on 5 May 2026. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood 4beta-hydroxycholesterol concentration (time frame: At the time point of the blood collection - cross-sectional. One day.). 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 5 May 2026.