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

Alcoholic Hepatitis Clinical Trial

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 Alcoholic Hepatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019056
• Other study ID #: MG
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2013
• Last updated: April 27, 2015
• Start date: November 2010
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: PharmaKing
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholic Fatty Liver Disease
• Alcoholic Hepatitis
• Fatty Liver
• Fatty Liver, Alcoholic
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic
• Liver Diseases

Intervention

Drug:
• Placebo /bid P.O

• MG-1

• MG-2 : MG1000mg, Placebo /bid P.O

• metadoxine

Locations

Country	Name	City	State
Korea, Republic of	Hanyang university Hospital	Guri city	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
PharmaKing

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	To evaluate ALT normalization	To evaluate ALT normalization assessed by comparing the percentage.	14weeks	No
Primary	To evaluate AST normalization	To evaluate AST normalization assessed by comparing the percentage.	14weeks	No
Primary	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	No