Efficacy of Simvastatin in Alcoholic Liver Fibrosis

NCT04971577 | Recruiting Phase 2 DMC

• 1 other identifier: SIMFIB
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Fibrosis; Alcohol Abuse

Outcome Measures

Primary Outcomes (1)

• Change from baseline biopsy in histological fibrosis Ishak score (0-4 range. higher scores mean a worse result)

  Change from range baseline biopsy in histological fibrosis score measured through the Ishak scale at 18 months.

  18 months

Study Arms (2)

Control arm

PLACEBO COMPARATOR

Drug: Simvastatin 40mg

Treatment arm

EXPERIMENTAL

Drug: Simvastatin 40mg

Interventions

Simvastatin 40mg DRUG

participants will receive a capsule containing 4 tablets simvastatin 10 mg (40 mg total) every 24 hours at night

Control arm; Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 need of diuretic treatment in the previous 12 months to control ascites or hydrothorax.
• Spontaneous bacterial peritonitis within 12 months prior to study enrollment.
• Hepatocellular carcinoma of any stage.
• Patients with known muscle disease.
• Patients with previous rhabdomyolysis.
• Patients being treated with strong CYP3A4 enzyme inhibitors (see section 5.2: Concomitant drugs, not allowed and allowed).
• Patients being treated with drugs with possible interactions with simvastatin (see section 5.2: Concomitant drugs, not allowed and allowed).
• Patients with a history of significant extrahepatic disease with poor short-term prognosis, including New York Heart Association Grade III / V congestive heart failure, GOLD COPD\> 2, chronic kidney disease with serum creatinine\> 2mg / dL or under therapy of kidney replacement.
• Patients with extrahepatic malignancies, including solid tumors and hematologic malignancies.
• Patients with a history or increased risk of intestinal obstruction.
• Pregnancy or breastfeeding.
• Patients included in other clinical trials during the previous month.
• Patients with mental disabilities, language barriers, poor social support or any other reason considered by the researcher as essential for adequate understanding, cooperation or compliance with the study.

Sponsors & Collaborators

• Anna Cruceta: lead

Study Sites (1)

Jordi Gratacos

Barcelona, 08036, Spain

RECRUITING

Related Publications (1)

• Luo X, Wang G, Yang L, Hernandez-Gea V. Future research direction of portal hypertension based on Baveno VII. Chin Med J (Engl). 2025 Sep 20;138(18):2268-2282. doi: 10.1097/CM9.0000000000003785. Epub 2025 Aug 18.

  PMID: 40824526 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Alcoholism

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Pere Gines, Md

  Hospital Clinic of Barcelona

  STUDY CHAIR

Central Study Contacts

Gratacos

CONTACT

34 932275400; acruceta@recerca.clinic.cat

ana cruceta

CONTACT

34-932275400; acruceta@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: February 22, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

ES (1)