Liver Function FailurePhase 3NCT03216668
TONKA Versus Legalon for Lowering Hepatic Enzymes in Liver Function Disorder Patients.
A Phase 3 study testing TONKA and LEGALON in people with Liver Function Failure, run by Nhat Nhat Pharmaceutical Company at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Function Failure
- What is being tested?
- TONKA and LEGALON
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Jun 2017to 30 Sep 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hepatitis B or C.
- Pregnant or Lactating women
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Hue Central General Hospital
Huế
Phuong Tran, BA., 84.72.3817 117, lienhe@nhatnhat.com
Pham Nhu Hiep, Prof
About this study
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
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.
- Conditions
- Liver Function Failure
- Being tested
- TONKA, LEGALON
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TONKADrug
Administered orally twice a day, 2 tablets each time, for 6 weeks.
LEGALONDrug
Administered orally three times a day, two tablets each time, for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| TONKA | Experimental | Administered orally twice a day, 2 tablets each time, for 6 weeks Receives: Drug: TONKA |
| LEGALON | Active comparator | Administered orally three times a day, two tablets each time, for 6 weeks Receives: Drug: LEGALON |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 weeks
Secondary outcomes (26)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 weeks
The absolute change from Baseline to 3 weeks in ALT, compared between Tonka and Silymarin (Legalon)
Measured: 3 weeks
The absolute change from Baseline to 6 weeks in ALT, compared between Tonka and Silymarin (Legalon)
Measured: 6 weeks
The absolute change from Baseline to 3 weeks in AST, compared between Tonka and Silymarin (Legalon)
Measured: 3 weeks
The absolute change from Baseline to 6 weeks in AST, compared between Tonka and Silymarin (Legalon)
Measured: 6 weeks
The absolute change from Baseline to 3 weeks in GGT, compared between Tonka and Silymarin (Legalon)
Measured: 3 weeks
The absolute change from Baseline to 6 weeks in GGT, compared between Tonka and Silymarin (Legalon)
Measured: 6 weeks
The absolute change from Baseline to 3 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)
Measured: 3 weeks
The absolute change from Baseline to 6 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon)
Measured: 6 weeks
The number of participants with other clinically significant laboratory parameters at week 6, compared between Tonka and Silymarin (Legalon).
Measured: 6 weeks
The number of participants with clinically significant vital sign parameters at week 6, compared between Tonka and Silymarin (Legalon).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start15 Jun 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Function FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomization
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nhat Nhat Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216668
- Sponsor's protocol ID
- TONKA-V3
- Status last verified
- Oct 2018
- First submitted
- 9 Jul 2017
- Last updated
- 23 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03216668
- Acronym / sponsor ID
- TONKA-V3
- Conditions
- Liver Function Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Nhat Nhat Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Block randomization
| Arm | Type | Receives |
|---|---|---|
| TONKA | Experimental | Drug: TONKAAdministered orally twice a day, 2 tablets each time, for 6 weeks |
| LEGALON | Active comparator | Drug: LEGALONAdministered orally three times a day, two tablets each time, for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Hepatitis B or C.
- Pregnant or Lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TONKAAdministered orally twice a day, 2 tablets each time, for 6 weeks. | Drug | TONKA |
| LEGALONAdministered orally three times a day, two tablets each time, for 6 weeks | Drug | LEGALON |
Primary outcome
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
26 secondary outcomes
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 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 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 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 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 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 upper normal limit (UNL) 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 upper normal limit (UNL) 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 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 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 6 weeks of treatment, compared between Tonka and Silymarin (Legalon)
Time frame: 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
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 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 3 weeks in ALT, compared between Tonka and Silymarin (Legalon)
Time frame: 3 weeks
The absolute change from Baseline to 6 weeks in ALT, compared between Tonka and Silymarin (Legalon)
Time frame: 6 weeks
The absolute change from Baseline to 3 weeks in AST, 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 absolute change from Baseline to 3 weeks in GGT, compared between Tonka and Silymarin (Legalon)
Time frame: 3 weeks
The absolute change from Baseline to 6 weeks in GGT, 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 Total Bilirubin, 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TONKA and LEGALON in people with Liver Function Failure, run by Nhat Nhat Pharmaceutical Company at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Phuong Tran, BA (84.72.3817 117, lienhe@nhatnhat.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.