NCT02200029

Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption

Open-Label Study With Ademetionine (Heptral®) in Subjects With Intrahepatic Cholestasis (IHC) Associated With Alcoholic Liver Disease (ALD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with liver disease has shown that ademetionine is effective.

Conditions

• Intrahepatic Cholestasis Associated With Alcoholic Liver Disease

Interventions

Type	Name	Description
DRUG	Ademetionine IV+tablet	IV ademetionine (500 mg/vial) for 2 weeks followed by oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 6 weeks
DRUG	Ademetionine tablet	oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 8 weeks

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-07-25
• Last updated: 2015-06-16

Locations

12 sites across 1 country: Russia