NCT04216693

Digoxin for Patients With Non-alcoholic Steatohepatitis (NASH)

Efficacy and Safety of Digoxin in the Treatment of Adults Patients With Non-alcoholic Steatohepatitis: a Multi-center, Randomized, Placebo-controlled Trial

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess if digoxin is safe and efficacious in treating patients with non-alcoholic steatohepatitis (NASH) within the approved target range of 0.7 to 1 ng/ml.

Detailed description

This study is a phase II, open labeled, multi-center, prospective, randomized, placebo controlled clinical trial to evaluate the efficacy and safety of digoxin in the treatment of nonalcoholic steatohepatitis. The participants will take study drug digoxin, which is approved by FDA for the treatment of congestive heart failure (CHF), orally daily based on the body weight, titrated to the level of 0.7 to 1 ng/ml for total of 6 cycles (4 weeks/cycle). A liver biopsy will be performed at the beginning of the study and 24 weeks after randomization to evaluate the efficacy of digoxin in the treatment of nonalcoholic steatohepatitis.

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Digoxin tablet	The NASH patients in experimental group will take digoxin tablets orally with the goal of achieving a serum digoxin concentration of 0.7-1 ng/ml for 24 weeks.
OTHER	Placebo	The control group will receive the digoxin-like placebo treatment.

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-12-01
• Completion: 2023-06-01
• First posted: 2020-01-03
• Last updated: 2023-02-22

Locations

1 site across 1 country: China