NCT03150459

Simvastatin Plus Rifaximin in Decompensated Cirrhosis

Safety and Tolerability of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis: a Multicenter, Double-blind, Placebo Controlled Randomized Clinical Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Judit Pich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to investigate whether the combination of two different drugs, simvastatin and rifaximin, is safe in the treatment of patients with decompensated cirrhosis. The secondary purpose is to see if this combination results in an improvement in inflammation markers in patients with cirrhosis and in an improvement in analytic parameters of progression of liver disease.

Detailed description

Cirrhosis is the final stage of liver diseases, and currently, there is no effective treatment, with liver transplantation being the only curative solution in selected patients. As the number of donor organs for liver transplantation is limited and criteria for transplantation are strict, the current management of cirrhosis consists of treating its complications. However, there is no effective therapy that prevents or cures the disease itself. Rifaximin is an antibiotic that acts in the gastrointestinal tract. It is poorly absorbed to the general circulation and has low toxicity and good tolerability. Itis currently approved for use in patients with cirrhosis to prevent recurrent hepatic encephalopathy. Rifaximin decreases the transit of bacteria and bacterial products from the gut to the general circulation, preventing the chronic inflammation that takes place in cirrhotic patients. Recent investigations have shown that simvastatin, a drug which is widely used to treat high cholesterol levels for the prevention of cardiovascular diseases, may have beneficial effects in patients with cirrhosis by preventing the progression of the disease and its complications. Although in the past decades there was a concern about its use in patients with liver disease due to its rare adverse effects (liver and muscle toxicity), recent clinical trials have shown that it can be safely used in patients with cirrhosis. LIVERHOPE\_SAFETY clinical trial have been designed to investigate whether the combination of these two drugs is safe in patients with cirrhosis, and also if it has potential beneficial effects in decreasing inflammation and improving analytical markers of progression of liver disease.

Conditions

• Cirrhoses, Liver

Interventions

Type	Name	Description
DRUG	Simvastatin 20 mg	Simvastatin 20 mg/day for 12 weeks (Group 1)
DRUG	Simvastatin 40mg	Simvastatin 40 mg/day for 12 weeks (Group 2)
DRUG	Rifaximin 400 mg	Rifaximin 400 mg/8 hours for 12 weeks (Group 1 and 2)
OTHER	Placebo of Simvastatin	Placebo of Simvastatin for 12 weeks (Group 3)
OTHER	Placebo of Rifaximin	Placebo of Rifaximin for 12 weeks (Group 3)

Timeline

• Start date: 2017-07-26
• Primary completion: 2018-03-12
• Completion: 2018-03-12
• First posted: 2017-05-12
• Last updated: 2019-03-28

Locations

9 sites across 6 countries: France, Germany, Italy, Netherlands, Spain, United Kingdom