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

Phase 2

Completed

• Conditions: Alcoholic Fatty Liver Disease; Alcoholic Hepatitis
• Interventions: Drug: metadoxine; Drug: Placebo /bid P.O; Drug: MG-1

• Registration Number: NCT02019056
• Lead Sponsor: PharmaKing

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 Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-24
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metadoxine 500mg	metadoxine	enteric coated capsule
Placebo	Placebo /bid P.O	enteric coated capsule
MG 500mg	MG-1	Metadoxine + garlic oil

Primary Outcome Measures

Name	Time	Method
To evaluate ALT normalization	14weeks	To evaluate ALT normalization assessed by comparing the percentage.
change in AST, ALT, total lab billirubin lab value	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
Change from Baseline in AST at 14weeks	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)	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 AST normalization	14weeks	To evaluate AST normalization assessed by comparing the percentage.

Trial Locations

Locations (1)

Hanyang university Hospital; 🇰🇷 Guri city, Gyeonggi-do, Korea, Republic of