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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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