Efficacy of Simvastatin in Alcoholic Liver Fibrosis

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnna Cruceta

About this trial

Evaluate the efficacy of simvastatin in reducing liver fibrosis in patients with advanced fibrosis due to alcohol

Eligibility criteria

Qualifiers

Age ≥ 18 years

Chronic alcohol-related liver disease according to international guidelines (EASL, European Association for the Study of the Liver) and with data of significant liver fibrosis obtained in the diagnostic biopsy at the beginning of the study or in the last biopsy of the patient within 6 months prior to randomization. Significant liver fibrosis is defined by a score on the Ishak fibrosis scale of between 3 and 6.

Patients in the compensated chronic liver disease phase defined by the absence of clinical decompensations at the time of entering the study, with or without data of portal hypertension.

Women of childbearing potential must have a negative urine pregnancy test prior to study enrollment and agree to use highly effective contraceptive methods (combined oral pill, injectable or implanted contraceptive, intrauterine device / hormone delivery system intrauterine) during the study.

Disqualifiers

Patients receiving statins or fibrates.

Patients with other etiologies of liver disease in addition to alcohol: hepatitis C, hepatitis B, autoimmune hepatitis, Wilson's disease, or hemochromatosis.

Patients in whom hepatitis C has been cured with antivirals in the 2 years prior to inclusion in the study.

Patients with a CK elevation of 50% or more above the upper limit of normal at the time of study inclusion.

Trial design

Treatments tested in this trial

  • Simvastatin 40mg

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Anna Cruceta

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Sponsor institution