NCT02024295

Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.

Detailed description

randomize first time for core treatment stage for 6 weeks, then randomized second time for extend treatment for 42 weeks.

Conditions

• Hepatitis, Alcoholic

Interventions

Type	Name	Description
DRUG	Ademethionine	ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
DRUG	Polyene Phosphatidyl choline	Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
DRUG	Ademethionine	after 6 weeks of core treatment stage, then ademethionine 1000mg bid or qd orally for 42 weeks

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-12-31
• Last updated: 2014-05-29

Locations

2 sites across 1 country: China