Liver FibrosisPhase 2/3SIMFIBNCT04971577
Efficacy of Simvastatin in Alcoholic Liver Fibrosis
A Phase 2/3 study testing Simvastatin 40mg in people with Liver Fibrosis and Alcohol Abuse, run by Anna Cruceta at 1 site in Spain.
Trial summary
Evaluate the efficacy of simvastatin in reducing liver fibrosis in patients with advanced fibrosis due to alcohol Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis, Alcohol Abuse
- What is being tested?
- Simvastatin 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 22 Feb 2022to Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Jordi Gratacos
Barcelona, 08036
ana cruceta, 93 2275400, acruceta@recerca.clinic.cat
ana cruceta, 392275400, acruceta@recerca.clinic.cat
About this study
Official title: 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
- Conditions
- Liver Fibrosis, Alcohol Abuse
- Being tested
- Simvastatin 40mg
- Medical subject headings
- Liver Cirrhosis, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 40mgDrug
participants will receive a capsule containing 4 tablets simvastatin 10 mg (40 mg total) every 24 hours at night
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Placebo comparator | Not described Receives: Drug: Simvastatin 40mg |
| Treatment arm | Experimental | Not described Receives: Drug: Simvastatin 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start22 Feb 2022
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Cruceta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Pere Gines, Md, Study chair, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971577
- Sponsor's protocol ID
- SIMFIB
- Acronym
- SIMFIB
- Status last verified
- Dec 2024
- First submitted
- 12 Jul 2021
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40824526
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Simvastatin in Reducing Liver Fibrosis in Patients With Advanced Fibrosis Due to Alcohol: Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04971577
- Acronym / sponsor ID
- SIMFIB / SIMFIB
- Conditions
- Liver Fibrosis, Alcohol Abuse
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Anna CrucetaUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy of simvastatin in reducing liver fibrosis in patients with advanced fibrosis due to alcohol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Placebo comparator | Drug: Simvastatin 40mg |
| Treatment arm | Experimental | Drug: Simvastatin 40mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatin 40mgparticipants will receive a capsule containing 4 tablets simvastatin 10 mg (40 mg total) every 24 hours at night | Drug | Control arm, Treatment arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 40824526Luo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pere Gines, Md study chair
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Simvastatin 40mg in people with Liver Fibrosis and Alcohol Abuse, run by Anna Cruceta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gratacos (34 932275400, acruceta@recerca.clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline biopsy in histological fibrosis Ishak score (0-4 range. higher scores mean a worse result) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04971577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.