Skip to main content
OpenTrials
Completed

NCT Number: NCT02019056

Efficacy and Safety of MG in the 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcoholic Fatty Liver Disease Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholic Hepatitis Chemically-Induced Disorders Digestive System Diseases Fatty Liver Fatty Liver, Alcoholic Hepatitis Hepatitis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hanyang university Hospital

Guri-si, Gyeonggi-do, 471-701, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo /bid P.O

Drug

MG-1

Drug

Other names: MG500mg,Placebo /bid P.O

MG-2 : MG1000mg, Placebo /bid P.O

Drug

Metadoxine

Drug

Other names: placebo, metadoxine 500mg/ bid P.O

Primary outcomes

  1. 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

  2. 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.

  3. To evaluate ALT normalization

    Time frame: 14weeks

    To evaluate ALT normalization assessed by comparing the percentage.

  4. To evaluate AST normalization

    Time frame: 14weeks

    To evaluate AST normalization assessed by comparing the percentage.

  5. 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

Sponsors and collaborators

Lead sponsor

PharmaKing

Industry

Registry information

Official study 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 Alcoholic Hepatitis

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 24, 2013
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.