Efficacy of simvastatin for the reduction of alcohol-induced liver fibrosis.

Phase 1

• Conditions: reduction of liver fibrosis in patients with advanced fibrosis due to alcohol; MedDRA version: 20.1Level: PTClassification code 10001627Term: Alcoholic liver diseaseSystem Organ Class: 10019805 - Hepatobiliary disorders; MedDRA version: 20.0Level: PTClassification code 10019668Term: Hepatic fibrosisSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2020-006023-33-ES
• Lead Sponsor: Institut d’Investigacions Biomèdiques August Pi i Sunyer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-23
• Last Update Posted: 3 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

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) (ishak 3-6)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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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.Child-Pugh > 8
10. Hepatocellular carcinoma of any stage.
11. Patients with known muscle disease.
12. Patients with previous rhabdomyolysis.
13. Patients being treated with strong CYP3A4 enzyme inhibitors (see section 5.2: Concomitant drugs, not allowed and allowed).
14. Patients being treated with drugs with possible interactions with simvastatin (see section 5.2: Concomitant drugs, not allowed and allowed).
15. 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.
16. Patients with extrahepatic malignancies, including solid tumors and hematologic malignancies.
17. Patients with a history or increased risk of intestinal obstruction.
18. Pregnancy or breastfeeding.
19. Patients included in other clinical trials during the previous month.
20. 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.
21. Presence of data on alcoholic hepatitis in liver biopsy upon inclusion.
22. Patients with contraindications for statins.
23. Known hypersensitivity to simvastatin.
24. Refusal to sign the informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified