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

October 20, 2018 updated by: Nhat Nhat Pharmaceutical Company

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hue, Vietnam
        • Recruiting
        • Hue Central General Hospital
        • Contact:
        • Principal Investigator:
          • Pham Nhu Hiep, Prof
        • Sub-Investigator:
          • Phan Thi Minh Huong, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TONKA
Administered orally twice a day, 2 tablets each time, for 6 weeks
Drug: TONKA
Administered orally twice a day, 2 tablets each time, for 6 weeks.
Active Comparator: LEGALON
Administered orally three times a day, two tablets each time, for 6 weeks
Drug: LEGALON
Administered orally three times a day, two tablets each time, for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 weeks
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
6 weeks
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
3 weeks
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
6 weeks
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
3 weeks
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
6 weeks
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
3 weeks
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
6 weeks
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
3 weeks
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
6 weeks
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
3 weeks
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
6 weeks
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
3 weeks
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
6 weeks
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
3 weeks
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
6 weeks
The absolute change from Baseline to 3 weeks in ALT, compared between Tonka and Silymarin (Legalon)
Time Frame: 3 weeks
3 weeks
The absolute change from Baseline to 6 weeks in ALT, compared between Tonka and Silymarin (Legalon)
Time Frame: 6 weeks
6 weeks
The absolute change from Baseline to 3 weeks in AST, compared between Tonka and Silymarin (Legalon)
Time Frame: 3 weeks
3 weeks
The absolute change from Baseline to 6 weeks in AST, compared between Tonka and Silymarin (Legalon)
Time Frame: 6 weeks
6 weeks
The absolute change from Baseline to 3 weeks in GGT, compared between Tonka and Silymarin (Legalon)
Time Frame: 3 weeks
3 weeks
The absolute change from Baseline to 6 weeks in GGT, compared between Tonka and Silymarin (Legalon)
Time Frame: 6 weeks
6 weeks
The absolute change from Baseline to 3 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)
Time Frame: 3 weeks
3 weeks
The absolute change from Baseline to 6 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)
Time Frame: 6 weeks
6 weeks
The number of participants with other clinically significant laboratory parameters at week 6, compared between Tonka and Silymarin (Legalon).
Time Frame: 6 weeks
6 weeks
The number of participants with clinically significant vital sign parameters at week 6, compared between Tonka and Silymarin (Legalon).
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Outcome Measure
Time Frame
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
week 6, week 10
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
week 6, week 10
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
week 6, week 10
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
week 6, week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nhat Nhat Pharmaceutical Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2017

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

July 9, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 20, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TONKA-V3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Function Failure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe