Clinical Trial: Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled,Phase 2 Study to Evaluate the Efficacy, Safety of MG in Patients With Alcoholic Fatty Liver Disease and Alcohol

Brief Summary: The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of MG in Patients With alcoholic Fatty Liver Disease and Alcoholic Hepatitis.

Detailed Summary:
Sponsor: PharmaKing

Current Primary Outcome:

• Change from Baseline in AST at 14weeks [ Time Frame: 14Weeks ]
  To evaluate the liver function to assess improvement of the MG on change in AST lab value assessed from baseline to 12 weeks in patients with Alcoholic fatty liver disease
• Number of Participants with Adverse Events (Safety) [ Time Frame: 14weeks ]
  Adverse Event: Physical examine, Lab test, Vital sign, ECG, symptom, start day and time, end day and time, severity, progress, outcome, relation with investigational product.
• To evaluate ALT normalization [ Time Frame: 14weeks ]
  To evaluate ALT normalization assessed by comparing the percentage.
• To evaluate AST normalization [ Time Frame: 14weeks ]
  To evaluate AST normalization assessed by comparing the percentage.
• change in AST, ALT, total lab billirubin lab value [ Time Frame: 14weeks ]
  To evaluate the efficacy of the MG on change in AST, ALT, total lab billirubin lab value assessed from baseline to 4, 8, 12 weeks in patients with Alcoholic fatty liver disease

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: PharmaKing

Dates:
Date Received: October 30, 2013
Date Started: November 2010
Date Completion:
Last Updated: April 27, 2015
Last Verified: April 2015