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RecruitingNCT04971577SIMFIBUpdated Dec 4, 2024

Efficacy of Simvastatin in Alcoholic Liver Fibrosis

A Phase 2/3 interventional study of Simvastatin 40mg in Liver Fibrosis and Alcohol Abuse, sponsored by Anna Cruceta. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by Anna Cruceta · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2022; still recruiting 4 years 8 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Liver Fibrosis
  • Alcohol Abuse
03

In context

Liver Cirrhosis

1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.

This study's planned enrollment of 90 is above the median of 72 across 1,003 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Anna Cruceta is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 years
  2. 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.
  3. 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.
  4. 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

Exclusion Criteria:

  1. Patients receiving statins or fibrates.
  2. Patients with other etiologies of liver disease in addition to alcohol: hepatitis C, hepatitis B, autoimmune hepatitis, Wilson's disease, or hemochromatosis.
  3. Patients in whom hepatitis C has been cured with antivirals in the 2 years prior to inclusion in the study.
  4. Patients with a CK elevation of 50% or more above the upper limit of normal at the time of study inclusion.
  5. Gastrointestinal bleeding due to portal hypertension within 12 months prior to inclusion in the study.
  6. Clinical hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy, in the 12 months prior to inclusion in the study.
  7. Patients in need of diuretic treatment in the previous 12 months to control ascites or hydrothorax.
  8. Spontaneous bacterial peritonitis within 12 months prior to study enrollment.
  9. Hepatocellular carcinoma of any stage.
  10. Patients with known muscle disease.
  11. Patients with previous rhabdomyolysis.
  12. Patients being treated with strong CYP3A4 enzyme inhibitors (see section 5.2: Concomitant drugs, not allowed and allowed).
  13. Patients being treated with drugs with possible interactions with simvastatin (see section 5.2: Concomitant drugs, not allowed and allowed).
  14. 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.
  15. Patients with extrahepatic malignancies, including solid tumors and hematologic malignancies.
  16. Patients with a history or increased risk of intestinal obstruction.
  17. Pregnancy or breastfeeding.
  18. Patients included in other clinical trials during the previous month.
  19. 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.
  20. Presence of data on alcoholic hepatitis in liver biopsy upon inclusion.
  21. Patients with contraindications for statins.
  22. Known hypersensitivity to simvastatin.
  23. Refusal to sign the informed consent
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
90 participants (estimated)

Study arms

  • Placebo comparator
    Control arm

    Drug: Simvastatin 40mg

  • Experimental
    Treatment arm

    Drug: Simvastatin 40mg

Interventions

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

06

What researchers measure

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.

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2022 (actual). Primary completion is estimated for Mar 2027, 61 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2021
First posted
Jul 21, 2021
StartActual
Feb 22, 2022
Primary completionEst.
Mar 2027
CompletionEst.
Dec 2027
Last update
Dec 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04971577
Lead sponsor
Anna Cruceta
Responsible party
Anna Cruceta (Project manager, Fundacion Clinic per a la Recerca Biomédica) — Sponsor-investigator
First posted
Jul 21, 2021
Start date
Feb 22, 2022
Primary completion
Mar 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Dec 4, 2024

Study contacts

Gratacos
Contact
acruceta@recerca.clinic.cat
34 932275400
ana cruceta
Contact
acruceta@recerca.clinic.cat
34-932275400
Pere Gines, Md
study chair · Hospital Clinic of Barcelona

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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