NCT04199910

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Dec 2019Dec 2027

Study Start

First participant enrolled

December 1, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

8.1 years

First QC Date

December 11, 2019

Last Update Submit

April 28, 2026

Conditions

Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

  • Blood 4beta-hydroxycholesterol concentration

    Blood 4beta-hydroxycholesterol concentration

    At the time point of the blood collection - cross-sectional. One day.

Study Arms (6)

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

Interventions

There is no intervention, only research blood samples are collectedOTHER

Research blood samples collected

Crohn's diseaseLiver cirrhosis with rifaximinLiver cirrhosis with spironolactoneLiver cirrhosis without spironolactone or rifaximinPneumoniaUlcerative colitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cirrhosis, pneumonia, Crohn's disease or colitis ulcerosa treated in the ward 42 of the Oulu University Hospital

You may qualify if:

  • Patients with cirrhosis, pneumonia, Crohn's disease or colitis ulcerosa
  • Treated in the ward 42 of the Oulu University Hospital

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, 90029 OYS, Finland

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Janne Hukkanen, MD

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 16, 2019

Study Start

December 1, 2019

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

FI(1)