Statins for Prevention of Disease Progression and Hospitalization in Liver Cirrhosis (STATLiver)
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|ClinicalTrials.gov Identifier: NCT04072601|
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : December 2, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhoses||Drug: Placebo oral tablet Drug: Atorvastatin 10mg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Allocation and randomisation is blinded. Participants are only identified by randomisation number (no group names) Allocation ratio is 1:1 All personnel and participants are blinded through the study period. All outcome assessors are blinded to treatment.|
|Official Title:||Statins for Prevention of Disease Progression and Hospitalization in Liver Cirrhosis: A Multi-center, Randomized, Double Blind, Placebo-controlled Trial. The STATLiver Trial|
|Actual Study Start Date :||November 8, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2028|
Atorvastatin 10-20 mg for 18 months of treatment. Start dose is 10 mg, adjusted to 20 mg after 15-30 days if no sideeffects occurs.
Drug: Atorvastatin 10mg
Tablet, can be adjusted to 2 tablets if tolerated
Placebo Comparator: Control
Placebo of atorvastatin 10 mg, 1-2 tablets for 18 months of treatment. Start dose is 1 tablet (10 mg placebo), adjusted to 2 tablets (20 mg placebo) after 15-30 days if no side effects occurs.
Drug: Placebo oral tablet
Lactose monohydrate 50 mg, potato starch 45 mg, Gelatine 1,2 mg, Magnesium stearate 0,5, Talc 4,5 mg
- Composite endpoint of numbers of death or liver transplantation [ Time Frame: 1.5 years ]
- Number of hospitalizations with liver related complications [ Time Frame: 1.5 years ]
- Patient survival [ Time Frame: 1.5 and 5 years ]
- Number of adverse events [ Time Frame: 1.5 years (18 months) ]
- Number of Patients developing decompensation of liver cirrhosis [ Time Frame: 1.5 and 5 years ]
- Time to first hospital admission due to decompensation or complications of liver cirrhosis [ Time Frame: 1.5 and 5 years ]
- Numbers of episodes of decompensation [ Time Frame: 1.5 and 5 years ]
- Inflammation and macrophage activation [ Time Frame: 0.5 and 1.5 years ]Markers of systemic inflammation (TNF-alfa, IL4, IL10, IL 18, hsCRP) and macrophage activation (CD163, surface Mannose receptor) is measured before and after intervention
- Change in clinical score Child-Turcotte-Pugh [ Time Frame: 0.5 and 1.5 years ]Child score, a sum of point given on five parameters: P-albumin, P-bilirubin, Coagulation factor II,VII,X; presence of ascites and presence of hepatic encephalopathy. Score range: 5-15 with high score predicting af worse outcome
- Change in clinical score [ Time Frame: 0.5, 1.5 years ]MELD score a calculated score including parameters of bilirubin, INR, and creatinin levels. The score is calculated using log values. Range 5->30, with a higher score indicating worse outcome for patients.
- Change in clinical score, Frailty Index [ Time Frame: 0.5, 1.5 years ]Frailty Index, a questionnaire based on patients selfperceived health and performance. This score is under development and validation during this and other trials.
- Change in clinical score [ Time Frame: 0.5, 1.5 years ]Short Physical performance battery, a combined score of three physical tests, chair.-stand, gait speed and balance. Range 0-12 points, a high score indicates better physical performance.
- Cell activation [ Time Frame: 0.5 years ]Gene activation by transcriptomics of mRNA in the hepatic stellate cell, combined with protein activity by mass spectrometry proteomics
- Protein activity in the hepatic stellate cell [ Time Frame: 0.5 years ]By high-sensitivity Mass spectrometry-based proteomics, we will perform proteomics analysis of hepatic stellate cells and Kupffer cells under atorvastatin influence
- Composite endpoint of numbers of death or liver transplantation [ Time Frame: 5 years ]
- Number of hospitalization with liver related complications [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072601
|Contact: Nina Kimer, PhD||45 email@example.com|
|Contact: Søren Møller, DmSci||45 firstname.lastname@example.org|
|Gastro Unit, medical Division, University Hospital Hvidovre||Recruiting|
|Hvidovre, Danmark, Denmark, 2650|
|Contact: Nina Kimer, PhD email@example.com|