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

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 Alcoholic Hepatitis

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.

Study Overview

• Status: Completed
• Conditions: Alcoholic Hepatitis; Alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: Placebo /bid P.O; Drug: MG-1; Drug: MG-2 : MG1000mg, Placebo /bid P.O; Drug: metadoxine

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Guri city, Gyeonggi-do, Korea, Republic of, 471-701
      • Hanyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• •Patients over 18, under 70 years of age

  • The chronic alcohol intake patients

    • Current the heavy drinker over 3month, Day the average alcohol consumption Male>=60g, Female>=40mg y-GTP increase Male>=75, Female>=35
  • Over 1.5 ratio of AST to ALT
  • Patients who have chronoc alcohol disease

Exclusion Criteria:

• Patients who have liver disease with the cause different with the alcohol except
• Patients who have pyridoxine allergy or history
• Patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, Wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc
• Patients taking other investigational product within 90 days prior to the participation in the study.
• Patients who has been taken any medications that could affect the treatment : hypoglycemic agents, colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, pentoxifylline, lont-term use of NSAIDs, statins, neuroleptics, anti convulsive medications, high-dose acetaminophen(>=2.5g/day)
• Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study
• Patient who considered ineligible for participation in the study as Investigator's judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; enteric coated capsule	Drug: Placebo /bid P.O
Experimental: MG 500mg; Metadoxine + garlic oil	Drug: MG-1; Other Names: MG500mg,Placebo /bid P.O
Experimental: MG 1000mg; Metadoxine + garlic oil	Drug: MG-2 : MG1000mg, Placebo /bid P.O
Sham Comparator: Metadoxine 500mg; enteric coated capsule	Drug: metadoxine; Other Names: placebo, metadoxine 500mg/ bid P.O

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in AST at 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	14Weeks
Number of Participants with Adverse Events (Safety)	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.	14weeks
To evaluate ALT normalization	To evaluate ALT normalization assessed by comparing the percentage.	14weeks
To evaluate AST normalization	To evaluate AST normalization assessed by comparing the percentage.	14weeks
change in AST, ALT, total lab billirubin lab value	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	14weeks

Collaborators and Investigators

• Sponsor: PharmaKing

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Estimate): April 29, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; RNA Virus Infections; Virus Diseases; Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Liver Diseases; Hepatitis; Hepatitis A; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hepatitis, Alcoholic; Fatty Liver, Alcoholic; Physiological Effects of Drugs; Micronutrients; Vitamins; Alcohol Deterrents; Vitamin B Complex; Pyridoxine; Metadoxine
• Other Study ID Numbers: MG