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

Liver Function Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03216668
• Other study ID #: TONKA-V3
• Status: Recruiting
• Phase: Phase 3
• Start date: June 15, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2018
• Source: Nhat Nhat Pharmaceutical Company
• Contact: Phuong Tran, BA
• Phone: 84.72.3817 117
• Email: lienhe[@]nhatnhat.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Failure
• Liver Function Failure

Intervention

Drug:
• TONKA
Administered orally twice a day, 2 tablets each time, for 6 weeks.
• LEGALON
Administered orally three times a day, two tablets each time, for 6 weeks

Locations

Country	Name	City	State
Vietnam	Hue Central General Hospital	Hue

Sponsors (1)

Lead Sponsor	Collaborator
Nhat Nhat Pharmaceutical Company

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The absolute change after treatment discontinuation from week 6 to week 10 in ALT , compared between Tonka and Silymarin (Legalon)		week 6, week 10
Other	The absolute change after treatment discontinuation from week 6 to week 10 in AST , compared between Tonka and Silymarin (Legalon)		week 6, week 10
Other	The absolute change after treatment discontinuation from week 6 to week 10 in GGT , compared between Tonka and Silymarin (Legalon)		week 6, week 10
Other	The absolute change after treatment discontinuation from week 6 to week 10 in Total Bilirubin, compared between Tonka and Silymarin (Legalon)		week 6, week 10
Primary	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)		6 weeks
Secondary	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)		3 weeks
Secondary	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)		6 weeks
Secondary	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)		3 weeks
Secondary	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)		6 weeks
Secondary	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)		3 weeks
Secondary	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)		6 weeks
Secondary	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)		3 weeks
Secondary	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)		6 weeks
Secondary	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)		3 weeks
Secondary	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)		6 weeks
Secondary	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)		3 weeks
Secondary	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)		6 weeks
Secondary	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)		3 weeks
Secondary	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)		6 weeks
Secondary	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)		3 weeks
Secondary	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)		6 weeks
Secondary	The absolute change from Baseline to 3 weeks in ALT, compared between Tonka and Silymarin (Legalon)		3 weeks
Secondary	The absolute change from Baseline to 6 weeks in ALT, compared between Tonka and Silymarin (Legalon)		6 weeks
Secondary	The absolute change from Baseline to 3 weeks in AST, compared between Tonka and Silymarin (Legalon)		3 weeks
Secondary	The absolute change from Baseline to 6 weeks in AST, compared between Tonka and Silymarin (Legalon)		6 weeks
Secondary	The absolute change from Baseline to 3 weeks in GGT, compared between Tonka and Silymarin (Legalon)		3 weeks
Secondary	The absolute change from Baseline to 6 weeks in GGT, compared between Tonka and Silymarin (Legalon)		6 weeks
Secondary	The absolute change from Baseline to 3 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)		3 weeks
Secondary	The absolute change from Baseline to 6 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)		6 weeks
Secondary	The number of participants with other clinically significant laboratory parameters at week 6, compared between Tonka and Silymarin (Legalon).		6 weeks
Secondary	The number of participants with clinically significant vital sign parameters at week 6, compared between Tonka and Silymarin (Legalon).		6 weeks