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Evaluate the efficacy of simvastatin in reducing liver fibrosis in patients with advanced fibrosis due to alcohol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Placebo Comparator |
| |
| Treatment arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin 40mg | Drug | participants will receive a capsule containing 4 tablets simvastatin 10 mg (40 mg total) every 24 hours at night |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gratacos | Contact | 34 932275400 | acruceta@recerca.clinic.cat | |
| ana cruceta | Contact | 34-932275400 | acruceta@recerca.clinic.cat |
| Name | Affiliation | Role |
|---|---|---|
| Pere Gines, Md | Hospital Clinic of Barcelona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordi Gratacos | Recruiting | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40824526 | Derived | 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. |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |