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Statins for Prevention of Disease Progression and Hospitalization in Liver Cirrhosis

NCT04072601 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-01-13

No results posted yet for this study

Summary

In a randomized, doubleblind and placebo-controlled trial we assess both clinical and cellular effects of atorvastatin in patients with liver cirrhosis.

162 participants will be allocated to atorvastatin 10-20 mg or placebo for 18 months. Clinical outcomes of survival, hospitalizations and safety will be evaluated. Also, the trial will investigate cellular functions in the liver by mass spectrometry proteomics, and single cell transcriptomics as well as exploring atorvastatin effects on different fenotypes by metagenomics.

Conditions

  • Liver Cirrhoses

Interventions

DRUG

Placebo oral tablet

Lactose monohydrate 50 mg, potato starch 45 mg, Gelatine 1,2 mg, Magnesium stearate 0,5, Talc 4,5 mg

DRUG

Atorvastatin 10mg

Tablet, can be adjusted to 2 tablets if tolerated

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Copenhagen University Hospital, Hvidovre

    lead OTHER

Principal Investigators

  • Thit M Kronborg, MD · Gastro Unit, Hvidovre University Hospital

  • Flemming Bendtsen, DmSci · Gastro Unit, Hvidovre University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-08
Primary Completion
2022-07-31
Completion
2023-01-10

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04072601 on ClinicalTrials.gov