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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03216668
• Date of registration: 09/07/2017
• Prospective Registration: No
• Primary sponsor: Nhat Nhat Pharmaceutical Company
• Public title: TONKA Versus Legalon for Lowering Hepatic Enzymes in Liver Function Disorder Patients.
• Scientific 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
• Date of first enrolment: June 15, 2017
• Target sample size: 140
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03216668
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Vietnam

Contacts

• Name: Phuong Tran, BA

• Name: Phuong Tran, BA.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Liver Function Failure

Intervention(s)

Drug: TONKA

Drug: LEGALON

Primary Outcome(s)

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(s)

The absolute change from Baseline to 6 weeks in ALT, compared between Tonka and Silymarin (Legalon) [Time Frame: 6 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]

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]

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]

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]

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]

The absolute change from Baseline to 3 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon) [Time Frame: 3 weeks]

The absolute change from Baseline to 6 weeks in AST, compared between Tonka and Silymarin (Legalon) [Time Frame: 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]

The absolute change from Baseline to 6 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon) [Time Frame: 6 weeks]

The absolute change from Baseline to 3 weeks in GGT, compared between Tonka and Silymarin (Legalon) [Time Frame: 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]

The number of participants with other clinically significant laboratory parameters at week 6, compared between Tonka and Silymarin (Legalon). [Time Frame: 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]

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]

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]

The absolute change from Baseline to 3 weeks in ALT, compared between Tonka and Silymarin (Legalon) [Time Frame: 3 weeks]

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]

The absolute change from Baseline to 3 weeks in AST, compared between Tonka and Silymarin (Legalon) [Time Frame: 3 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]

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]

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]

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]

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]

The absolute change from Baseline to 6 weeks in GGT, compared between Tonka and Silymarin (Legalon) [Time Frame: 6 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]

Secondary ID(s)

TONKA-V3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors