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TONKA Versus Legalon for Lowering Hepatic Enzymes in Liver Function Disorder Patients.

Primary Purpose

Liver Function Failure

Status
Unknown status
Phase
Phase 3
Locations
Vietnam
Study Type
Interventional
Intervention
TONKA
LEGALON
Sponsored by
Nhat Nhat Pharmaceutical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Function Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and Female more than 18 year old.
  • Diagnosed as Alcoholic Liver Disease (ALD), or Non Alcoholic Fatty Liver Disease (NAFLD), or Liver Function Disorders due to Drugs or Chemicals.
  • ALT at baseline is in between 150 U/L to 400 U/L
  • Sign the informed consent form

Exclusion Criteria:

  • Hepatitis B or C.
  • Pregnant or Lactating women

Sites / Locations

  • Hue Central General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TONKA

LEGALON

Arm Description

Administered orally twice a day, 2 tablets each time, for 6 weeks

Administered orally three times a day, two tablets each time, for 6 weeks

Outcomes

Primary Outcome Measures

The percentage of patients with ALT reduced to less than or equal to 60 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)

Secondary Outcome Measures

The percentage of patients with ALT reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with ALT reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with AST reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with AST reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with GGT reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with GGT reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with Total Bilirubin reduced to less than or equal to the upper normal limit (UNL) after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with Total Bilirubin reduced to less than or equal to the upper normal limit (UNL) after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with ALT reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with ALT reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with AST reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with AST reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with GGT reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with GGT reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with Total Bilirubin reduced to less than or equal to the 2 times of the upper normal limit (2xUNL) after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The percentage of patients with Total Bilirubin reduced to less than or equal to the 2 times of the upper normal limit (2xUNL) after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
The absolute change from Baseline to 3 weeks in ALT, compared between Tonka and Silymarin (Legalon)
The absolute change from Baseline to 6 weeks in ALT, compared between Tonka and Silymarin (Legalon)
The absolute change from Baseline to 3 weeks in AST, compared between Tonka and Silymarin (Legalon)
The absolute change from Baseline to 6 weeks in AST, compared between Tonka and Silymarin (Legalon)
The absolute change from Baseline to 3 weeks in GGT, compared between Tonka and Silymarin (Legalon)
The absolute change from Baseline to 6 weeks in GGT, compared between Tonka and Silymarin (Legalon)
The absolute change from Baseline to 3 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)
The absolute change from Baseline to 6 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)
The number of participants with other clinically significant laboratory parameters at week 6, compared between Tonka and Silymarin (Legalon).
The number of participants with clinically significant vital sign parameters at week 6, compared between Tonka and Silymarin (Legalon).

Full Information

First Posted
July 9, 2017
Last Updated
October 20, 2018
Sponsor
Nhat Nhat Pharmaceutical Company
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1. Study Identification

Unique Protocol Identification Number
NCT03216668
Brief Title
TONKA Versus Legalon for Lowering Hepatic Enzymes in Liver Function Disorder Patients.
Official Title
A Randomized, Active-Control, Open Label, Phase IIIb Study to Evaluate the Safety and Efficacy of TONKA Compared With Silymarin (Legalon) for Lowering Hepatic Enzymes in Liver Function Disorder Patients With Moderate to High Elevated Liver
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nhat Nhat Pharmaceutical Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy TONKA on the reduction of ALT and AST in moderate to severe liver enzyme elevated patients; compared with Silymarin (Legalon) after 6 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Function Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Block randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TONKA
Arm Type
Experimental
Arm Description
Administered orally twice a day, 2 tablets each time, for 6 weeks
Arm Title
LEGALON
Arm Type
Active Comparator
Arm Description
Administered orally three times a day, two tablets each time, for 6 weeks
Intervention Type
Drug
Intervention Name(s)
TONKA
Intervention Description
Administered orally twice a day, 2 tablets each time, for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
LEGALON
Intervention Description
Administered orally three times a day, two tablets each time, for 6 weeks
Primary Outcome Measure Information:
Title
The percentage of patients with ALT reduced to less than or equal to 60 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The percentage of patients with ALT reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
3 weeks
Title
The percentage of patients with ALT reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
6 weeks
Title
The percentage of patients with AST reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
3 weeks
Title
The percentage of patients with AST reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
6 weeks
Title
The percentage of patients with GGT reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
3 weeks
Title
The percentage of patients with GGT reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
6 weeks
Title
The percentage of patients with Total Bilirubin reduced to less than or equal to the upper normal limit (UNL) after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
3 weeks
Title
The percentage of patients with Total Bilirubin reduced to less than or equal to the upper normal limit (UNL) after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
6 weeks
Title
The percentage of patients with ALT reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
3 weeks
Title
The percentage of patients with ALT reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
6 weeks
Title
The percentage of patients with AST reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
3 weeks
Title
The percentage of patients with AST reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
6 weeks
Title
The percentage of patients with GGT reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
3 weeks
Title
The percentage of patients with GGT reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
6 weeks
Title
The percentage of patients with Total Bilirubin reduced to less than or equal to the 2 times of the upper normal limit (2xUNL) after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
3 weeks
Title
The percentage of patients with Total Bilirubin reduced to less than or equal to the 2 times of the upper normal limit (2xUNL) after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time Frame
6 weeks
Title
The absolute change from Baseline to 3 weeks in ALT, compared between Tonka and Silymarin (Legalon)
Time Frame
3 weeks
Title
The absolute change from Baseline to 6 weeks in ALT, compared between Tonka and Silymarin (Legalon)
Time Frame
6 weeks
Title
The absolute change from Baseline to 3 weeks in AST, compared between Tonka and Silymarin (Legalon)
Time Frame
3 weeks
Title
The absolute change from Baseline to 6 weeks in AST, compared between Tonka and Silymarin (Legalon)
Time Frame
6 weeks
Title
The absolute change from Baseline to 3 weeks in GGT, compared between Tonka and Silymarin (Legalon)
Time Frame
3 weeks
Title
The absolute change from Baseline to 6 weeks in GGT, compared between Tonka and Silymarin (Legalon)
Time Frame
6 weeks
Title
The absolute change from Baseline to 3 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)
Time Frame
3 weeks
Title
The absolute change from Baseline to 6 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)
Time Frame
6 weeks
Title
The number of participants with other clinically significant laboratory parameters at week 6, compared between Tonka and Silymarin (Legalon).
Time Frame
6 weeks
Title
The number of participants with clinically significant vital sign parameters at week 6, compared between Tonka and Silymarin (Legalon).
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
The absolute change after treatment discontinuation from week 6 to week 10 in ALT , compared between Tonka and Silymarin (Legalon)
Time Frame
week 6, week 10
Title
The absolute change after treatment discontinuation from week 6 to week 10 in AST , compared between Tonka and Silymarin (Legalon)
Time Frame
week 6, week 10
Title
The absolute change after treatment discontinuation from week 6 to week 10 in GGT , compared between Tonka and Silymarin (Legalon)
Time Frame
week 6, week 10
Title
The absolute change after treatment discontinuation from week 6 to week 10 in Total Bilirubin, compared between Tonka and Silymarin (Legalon)
Time Frame
week 6, week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and Female more than 18 year old. Diagnosed as Alcoholic Liver Disease (ALD), or Non Alcoholic Fatty Liver Disease (NAFLD), or Liver Function Disorders due to Drugs or Chemicals. ALT at baseline is in between 150 U/L to 400 U/L Sign the informed consent form Exclusion Criteria: Hepatitis B or C. Pregnant or Lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phuong Tran, BA
Phone
84.72.3817 117
Email
lienhe@nhatnhat.com
Facility Information:
Facility Name
Hue Central General Hospital
City
Hue
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phuong Tran, BA.
Phone
84.72.3817 117
Email
lienhe@nhatnhat.com
First Name & Middle Initial & Last Name & Degree
Pham Nhu Hiep, Prof
First Name & Middle Initial & Last Name & Degree
Phan Thi Minh Huong, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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TONKA Versus Legalon for Lowering Hepatic Enzymes in Liver Function Disorder Patients.

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