- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04971577
Efficacy of Simvastatin in Alcoholic Liver Fibrosis (SIMFIB)
September 18, 2023 updated by: Anna Cruceta
Efficacy of Simvastatin in Reducing Liver Fibrosis in Patients With Advanced Fibrosis Due to Alcohol: Randomized, Double-blind, Placebo-controlled Clinical Trial
Evaluate the efficacy of simvastatin in reducing liver fibrosis in patients with advanced fibrosis due to alcohol
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gratacos
- Phone Number: 34 932275400
- Email: acruceta@recerca.clinic.cat
Study Contact Backup
- Name: ana cruceta
- Phone Number: 34-932275400
- Email: acruceta@recerca.clinic.cat
Study Locations
-
-
-
Barcelona, Spain, 08036
- Recruiting
- Jordi Gratacos
-
Contact:
- ana cruceta
- Phone Number: 93 2275400
- Email: acruceta@recerca.clinic.cat
-
Contact:
- ana cruceta
- Phone Number: 392275400
- Email: acruceta@recerca.clinic.cat
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Gastrointestinal bleeding due to portal hypertension within 12 months prior to inclusion in the study.
- Clinical hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy, in the 12 months prior to inclusion in the study.
- 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.
- Presence of data on alcoholic hepatitis in liver biopsy upon inclusion.
- Patients with contraindications for statins.
- Known hypersensitivity to simvastatin.
- Refusal to sign the informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control arm
|
participants will receive a capsule containing 4 tablets simvastatin 10 mg (40 mg total) every 24 hours at night
|
Experimental: Treatment arm
|
participants will receive a capsule containing 4 tablets simvastatin 10 mg (40 mg total) every 24 hours at night
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline biopsy in histological fibrosis Ishak score (0-4 range. higher scores mean a worse result)
Time Frame: 18 months
|
Change from range baseline biopsy in histological fibrosis score measured through the Ishak scale at 18 months.
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Pere Gines, Md, Hospital Clinic of Barcelona
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2022
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
July 12, 2021
First Submitted That Met QC Criteria
July 20, 2021
First Posted (Actual)
July 21, 2021
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 18, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Digestive System Diseases
- Pathologic Processes
- Alcohol-Related Disorders
- Substance-Related Disorders
- Liver Diseases
- Fibrosis
- Alcoholism
- Liver Cirrhosis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Simvastatin
Other Study ID Numbers
- SIMFIB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Fibrosis
-
Alentis Therapeutics AGRecruitingLiver Cirrhosis | Advanced Liver FibrosisGermany, Romania, Slovakia
-
Bristol-Myers SquibbCompleted
-
University Hospital, AngersRecruitingScreening | Advanced Liver FibrosisFrance
-
University Hospital, GrenobleNot yet recruiting
-
The Affiliated Hospital of Qingdao UniversityRecruitingLiver Fibrosis After Liver Transplantation | Multiparameter Magnetic Resonance ImagingChina
-
Assistance Publique - Hôpitaux de ParisUnknownLiver Fibrosis Progression in Chronic Liver DiseaseFrance
-
Regina Elena Cancer InstituteFederico II UniversityRecruiting
-
Gilead SciencesTerminatedLiver Fibrosis Due to NASHUnited States, Canada, France, Italy, Germany, Puerto Rico, Spain, United Kingdom
-
King's College Hospital NHS TrustSamsung MedisonRecruitingHepatitis | Liver Fat | NAFLD | Fibrosis, Liver | Liver Disease Chronic | Liver Steatoses | NASH With FibrosisUnited Kingdom
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingNAFLD | Liver Fibrosis | NASH With FibrosisNetherlands
Clinical Trials on Simvastatin 40mg
-
Federal State Budgetary Scientific Institution,...Completed
-
University of Texas Southwestern Medical CenterTerminatedMuscle Cramp | Statin Adverse Reaction | Weakness, Muscle | AcheUnited States
-
University of Campinas, BrazilUnknownStroke | Sickle Cell DiseaseBrazil
-
Medical University of South CarolinaRecruitingProstate CancerUnited States
-
Bobbie Jo Rimel, MDRecruitingRecurrent Ovarian Cancer | Platinum-sensitive Ovarian CancerUnited States
-
Indonesia UniversityCompletedBreast Cancer | Chemotherapy EffectIndonesia
-
Annika BergquistRecruitingPrimary Sclerosing CholangitisSweden
-
Hue University of Medicine and PharmacyUniversità degli Studi di SassariUnknownChronic Kidney Diseases | HypercholesterolemiaVietnam
-
Hospital de Clinicas de Porto AlegreUnknown
-
Amsterdam UMC, location VUmcUnknownHypertension | Diabetes MellitusNetherlands