BridgeMD
Efficacy of IMP reducing liver fibrosis in patients with advanced fibrosis due to alcohol: a randomized, double-blind, placebo-controlled clinical trial.
EU CTIS ID: 2024-519968-41-00
What this study is testing
Proportion of patients with a significant reduction in the degree of liver fibrosis after treatment with simvastatin compared to placebo, analyzed through the histological evaluation of fibrosis using the Ishak scale, defined as a reduction in the fibrosis value of at least one point on the scale.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Patients receiving statins or fibrates.
- 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).
See the full eligibility 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.
- Patients receiving statins or fibrates.
- 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 an increased risk of intestinal obstruction.
- Pregnancy or breastfeeding.
- Patients included in other clinical trials during the previous month.
- Patients with other etiologies of liver disease in addition to alcohol: hepatitis C, hepatitis B, autoimmune hepatitis, Wilson's disease, or hemochromatosis.
- 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.
- 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 the 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 6 months to control ascites or hydrothorax.
- Spontaneous bacterial peritonitis within 12 months prior to study enrollment.
- Patients with a Child-Pugh score > 8 points.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.