Hepatitis B, ChronicPhase 4NCT05473806
Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes
A Phase 4 study testing Pioglitazone 15 Mg Oral Tablet and Evogliptin 5mg in people with Hepatitis B, Chronic and Fibrosis, Liver, run by Seung Up Kim at 4 sites in South Korea.
Trial summary
An exploratory comparison of changes in liver fibrosis through glycemic control within and between groups after administration of Pioglitazone and Evogliptin in chronic hepatitis B patients with type 2 diabetes and liver fibrosis Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatitis B, Chronic, Fibrosis, Liver, Diabetes Mellitus, Type 2
- What is being tested?
- Pioglitazone 15 Mg Oral Tablet and Evogliptin 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 18 Sep 2020to 19 Feb 2023
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged 20 or over and under 80 years of age
- Those who satisfy the following conditions among chronic hepatitis B patients diagnosed with type 2 diabetes.
- first. For the first diagnosis of type 2 diabetes: 6.5% ≤ HbA1c < 10.0%; second. Diagnosed with type 2 diabetes: HbA1c < 10.0%;
- Subjects who show significant liver fibrosis of 7 kilopascal or more in liver elasticity test using Fibroscan.
- Subjects who voluntarily sign the informed consent form after understanding the clinical study and being informed of the risks and benefits.
Who cannot join
- Those who are currently taking Pioglitazone or Evogliptin, or those who have stopped taking medication for less than 4 weeks.
- Patients meeting the criteria for alcoholic fatty liver (if alcohol intake exceeds 210 g per week for men and 140 g per week for women for the past 2 years)
- Cirrhosis patients with decreased liver function (CTP class B and C)
- Those taking drugs that can cause fatty liver (amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc.)
- Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis (within 24 weeks)
- In case of allergy or hypersensitivity reaction to the target drug or its components.
Show all 19Show fewer
- Patients treated with oral or parenteral corticosteroids chronically (>14 consecutive days) within 8 weeks prior to screening
- Malnutrition, starvation, and debilitating conditions (including patients with severe infections and severe trauma before and after surgery)
- Patients receiving or receiving radiation and chemotherapy for malignancy for less than 2 years.
- Heart failure (class III-IV in New York Heart Association classification) or uncontrolled arrhythmias within 24 weeks
- table. New York Heart Association Classification. Class I: Normal athletic ability; Class Ⅱ: Difficulty breathing, palpitations, chest pain, etc. appear due to daily exercise (fast walking or climbing a hill); Class Ⅲ: Symptoms appear with light exercise (walking on flat ground); Class IV: Symptoms appear even at rest;
- Patients with acute cardiovascular disease within 12 weeks (patients with a history of unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or coronary intervention)
- Patients with renal failure, chronic renal disease (estimated glomerular filtration rate <60 mL/min/1.73 m2) or patients on dialysis.
- Anemic patients with an Hb level of less than 10.5 g/dl.
- Pregnant or lactating women
- Patients who do not consent to the use of appropriate contraceptive methods during the clinical trial period only for women or men of childbearing potential.
- Patients who have taken clinical trial drugs from other clinical trials within 4 weeks of consenting to the document.
- Persons unable to participate in clinical trials due to the judgment of other researchers.
- Persons who cannot read consent forms (eg illiterate, foreigners, etc.)
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Gangnam Severance Hospital
Seoul
Samsung seoul Hospital
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
About this study
Official title: Prospective, Multicenter, Randomized, and Comparative Clinical Trials to Compare the Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes
An exploratory comparison of changes in liver fibrosis through glycemic control within and between groups after administration of Pioglitazone and Evogliptin in chronic hepatitis B patients with type 2 diabetes and liver fibrosis
Read the detailed description
Subjects who satisfy the selection/exclusion criteria and agree to participate in the clinical trial are randomly assigned to receive clinical trial drugs in a 1:1 ratio based on Visit 2 (Baseline) and take it for 24 weeks.
After that, visits are made at 12 and 24 weeks, and necessary tests are performed to confirm the improvement of liver fibrosis and to evaluate safety.
[Number of subjects and basis for calculation] The target number of test subjects is 40 in total, with 20 in each group (including 10% dropout rate).
The study design is an interventional study design comparing two test drugs, and it is intended to be performed as an exploratory study on safety and efficacy to confirm the possibility of entering a therapeutic confirmation trial.
The number of subjects was assumed by referring to the study on the measurement of liver fibrosis in NAFLD patients with type 2 diabetes in Reference which was conducted as hepatitis B patients with type 2 diabetes, the target disease of this clinical trial.
Significance level: 0.05 (two-sided test) statistical power: 90% Difference in the amount of change before and after treatment: 3.7 Standard deviation: 4.416324172 (Utilizing previous research results, the standard deviation of the difference was calculated by calculating the inverse function of the t distribution.)
G-power was used to calculate the number of subjects, and since this study is an exploratory comparative study between two groups and two independent groups, 18 people are needed per group, so a total of 36 people are needed. Considering dropout of about 10%, a total of 40 subjects, 20 in each group, will participate in this study.
[randomization] Randomization is based on a randomization table previously generated by a medical statistician. Therefore, the suitability of the subject is judged before the subject is randomly assigned to the two groups. Randomization will be conducted at a ratio of 1:1 to Test Group 1 and Test Group 2, respectively, based on the number of subjects for each clinical trial participating institution.
During clinical trial registration, subjects who have signed the consent form can only be identified with a unique subject identification code given to each subject instead of their name, and a random number will be continuously assigned by the researcher.
The randomization number is determined according to a computer-generated randomization code, and the randomization number determines the study drug group for the subject.
Randomization numbers are assigned sequentially according to the order of subject registration, and subjects will be continuously supplied with drugs based on the same dosing number during the clinical trial period.
Each Principal Investigator or Investigator shall check the randomization number assigned to each subject whenever a subject is enrolled in serial number order, and then start administration of the study drug accordingly. If a subject withdraws from the clinical trial, the randomization number assigned to the subject cannot be reused, and the subject cannot participate again in the trial.
- Being tested
- Pioglitazone 15 Mg Oral Tablet, Evogliptin 5mg
- Medical subject headings
- Hepatitis B, Chronic, Liver Cirrhosis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone 15 Mg Oral TabletDrug
Also called Gluconon tablet 15mg
24weeks dose
Evogliptin 5mgDrug
Also called SUGANON tablet 5mg
24weeks dose
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone 15mg | Experimental | pioglitazone hydrochloride. PO. 2 tablets once a day. Receives: Drug: Pioglitazone 15 Mg Oral Tablet |
| Evogliptin 5mg | Experimental | Evogliptin tartrate. PO. 1 tablets once a day. Receives: Drug: Evogliptin 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Liver Stiffness Measurement at 24 weeks compared to baseline.
It is measured based on the CAP score(db/m) and kilopascal from the liver fibroscan and evaluated by performing the paired-sample t-test or Wilcoxon signed test.
Measured: 24 weeks
Secondary outcomes (10)
Changes in Controlled Attenuation Parameter(CAP) value at 24 weeks compared to baseline.
The rate of decrease in the amount of fatty liver (CAP Value) measured at the end of the evaluation compared to the baseline is a descriptive statistic defined as [(Baseline CAP Value)- (Follow-up CAP Value)] / (Baseline CAP Value) × 100 (%) (mean, standard deviation, median, range (minimum, maximum)) are presented.
Measured: 24 weeks
Changes in HbA1c at 24 weeks compared to baseline.
After 24 weeks of treatment, the degree of change in HbA1c compared to baseline is defined as absolute difference = [= (Baseline HbA1c)-(Follow-up HbA1c)] and evaluated by performing paired-sample t-test or Wilcoxon signed-rank test.
Measured: 24 weeks
Changes in Insulin at 24 weeks compared to baseline.
After 24 weeks of treatment, the degree of change in Insulin compared to baseline is defined as absolute difference = [= (Baseline Insulin)-(Follow-up Insulin)] and evaluated by performing paired-sample t-test or Wilcoxon signed-rank test.
Measured: 24 weeks
Changes in lipid profile at 24 weeks compared to baseline.
After 24 weeks of treatment, the degree of change in lipid profile compared to baseline is defined as absolute difference = [= (Baseline lipid profile)-(Follow-up lipid profile)] and evaluated by performing paired-sample t-test or Wilcoxon signed-rank test.
Measured: 24 weeks
Changes in aspartate aminotransferase(AST)/alanine aminotransferase(ALT) at 24 weeks compared to baseline.
It is evaluated by performing paired-sample t-test or Wilcoxon signed rank test.
The proportion of subjects whose aspartate aminotransferase(AST)/alanine aminotransferase(ALT) recovered to normal values compared to baseline was Frequency and percentages are given and assessed using either the chi-square test or Fisher's exact test.
Measured: 24 weeks
Changes in Body weight at 24 weeks compared to baseline.
It is evaluated by performing paired-sample t-test or Wilcoxon signed rank test.
Measured: 24 weeks
Rate of side effects and discontinuation or change of drug after 24 weeks compared to baseline
It is evaluated by performing paired-sample t-test or Wilcoxon signed rank test.
Measured: 24 weeks
Analysis of predictors of improvement in liver fibrosis after 24 weeks compared to baseline.
It is analyzed the subject's fibroscan(CAP score(db/m) and kilopascal), body weight, aminotransferase(AST)/alanine aminotransferase(ALT), lipid profile, hepatitis serum markers(Hepatitis B surface antigen(HBsAg),Hepatitis B e-antigen(HBeAg),Anti-Hepatitis B e-antigen(Anti-HBe),Anti-Hepatitis B surface antigen(Anti-Hbs),Anti-hepatitis C virus(Anti-HCV)), drug compliance.
Measured: 24 weeks
Analysis of predictors of improvement of fatty liver after 24 weeks compared to baseline.
It is analyzed the subject's fibroscan(CAP score(db/m) and kilopascal), body weight, aminotransferase(AST)/alanine aminotransferase(ALT), lipid profile, hepatitis serum markers(Hepatitis B surface antigen(HBsAg),Hepatitis B e-antigen(HBeAg),Anti-Hepatitis B e-antigen(Anti-HBe),Anti-Hepatitis B surface antigen(Anti-Hbs),Anti-hepatitis C virus(Anti-HCV)), drug compliance.
Measured: 24 weeks
Analysis of predictors of HbA1c improvement after 24 weeks compared to baseline.
It is analyzed the subject's fibroscan(CAP score(db/m) and kilopascal), body weight, Homeostatic Model Assessment for Insulin Resistance, drug compliance.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start18 Sep 2020
- Primary completion19 Jan 2023 (estimated)
- Study completion19 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung Up Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seung Up Kim, Yonsei University
- Investigators
- Seung Up Kim, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473806
- Sponsor's protocol ID
- IIT-DASU-01
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized, and Comparative Clinical Trials to Compare the Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05473806
- Acronym / sponsor ID
- IIT-DASU-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Seung Up KimUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 19 Jan 2023 (estimated)
- Study completion
- 19 Feb 2023 (estimated)
- First posted
- 26 Jul 2022 (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.
An exploratory comparison of changes in liver fibrosis through glycemic control within and between groups after administration of Pioglitazone and Evogliptin in chronic hepatitis B patients with type 2 diabetes and liver fibrosis
Detailed description
Subjects who satisfy the selection/exclusion criteria and agree to participate in the clinical trial are randomly assigned to receive clinical trial drugs in a 1:1 ratio based on Visit 2 (Baseline) and take it for 24 weeks.
After that, visits are made at 12 and 24 weeks, and necessary tests are performed to confirm the improvement of liver fibrosis and to evaluate safety.
[Number of subjects and basis for calculation] The target number of test subjects is 40 in total, with 20 in each group (including 10% dropout rate).
The study design is an interventional study design comparing two test drugs, and it is intended to be performed as an exploratory study on safety and efficacy to confirm the possibility of entering a therapeutic confirmation trial.
The number of subjects was assumed by referring to the study on the measurement of liver fibrosis in NAFLD patients with type 2 diabetes in Reference which was conducted as hepatitis B patients with type 2 diabetes, the target disease of this clinical trial.
Significance level: 0.05 (two-sided test) statistical power: 90% Difference in the amount of change before and after treatment: 3.7 Standard deviation: 4.416324172 (Utilizing previous research results, the standard deviation of the difference was calculated by calculating the inverse function of the t distribution.)
G-power was used to calculate the number of subjects, and since this study is an exploratory comparative study between two groups and two independent groups, 18 people are needed per group, so a total of 36 people are needed. Considering dropout of about 10%, a total of 40 subjects, 20 in each group, will participate in this study.
[randomization] Randomization is based on a randomization table previously generated by a medical statistician. Therefore, the suitability of the subject is judged before the subject is randomly assigned to the two groups. Randomization will be conducted at a ratio of 1:1 to Test Group 1 and Test Group 2, respectively, based on the number of subjects for each clinical trial participating institution.
During clinical trial registration, subjects who have signed the consent form can only be identified with a unique subject identification code given to each subject instead of their name, and a random number will be continuously assigned by the researcher.
The randomization number is determined according to a computer-generated randomization code, and the randomization number determines the study drug group for the subject.
Randomization numbers are assigned sequentially according to the order of subject registration, and subjects will be continuously supplied with drugs based on the same dosing number during the clinical trial period.
Each Principal Investigator or Investigator shall check the randomization number assigned to each subject whenever a subject is enrolled in serial number order, and then start administration of the study drug accordingly. If a subject withdraws from the clinical trial, the randomization number assigned to the subject cannot be reused, and the subject cannot participate again in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone 15mg | Experimental | Drug: Pioglitazone 15 Mg Oral Tabletpioglitazone hydrochloride. PO. 2 tablets once a day. |
| Evogliptin 5mg | Experimental | Drug: Evogliptin 5mgEvogliptin tartrate. PO. 1 tablets once a day. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult aged 20 or over and under 80 years of age
- Those who satisfy the following conditions among chronic hepatitis B patients diagnosed with type 2 diabetes.
- first. For the first diagnosis of type 2 diabetes: 6.5% ≤ HbA1c < 10.0%; second. Diagnosed with type 2 diabetes: HbA1c < 10.0%;
- Subjects who show significant liver fibrosis of 7 kilopascal or more in liver elasticity test using Fibroscan.
- Subjects who voluntarily sign the informed consent form after understanding the clinical study and being informed of the risks and benefits.
Key exclusion criteria (19 listed)
- Those who are currently taking Pioglitazone or Evogliptin, or those who have stopped taking medication for less than 4 weeks.
- Patients meeting the criteria for alcoholic fatty liver (if alcohol intake exceeds 210 g per week for men and 140 g per week for women for the past 2 years)
- Cirrhosis patients with decreased liver function (CTP class B and C)
- Those taking drugs that can cause fatty liver (amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc.)
- Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis (within 24 weeks)
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 |
|---|---|---|
| Pioglitazone 15 Mg Oral TabletAlso: Gluconon tablet 15mg24weeks dose | Drug | Pioglitazone 15mg |
| Evogliptin 5mgAlso: SUGANON tablet 5mg24weeks dose | Drug | Evogliptin 5mg |
Primary outcome
Changes in Liver Stiffness Measurement at 24 weeks compared to baseline.
Time frame: 24 weeks
It is measured based on the CAP score(db/m) and kilopascal from the liver fibroscan and evaluated by performing the paired-sample t-test or Wilcoxon signed test.
10 secondary outcomes
Changes in Controlled Attenuation Parameter(CAP) value at 24 weeks compared to baseline.
Time frame: 24 weeks
Changes in HbA1c at 24 weeks compared to baseline.
Time frame: 24 weeks
Changes in Insulin at 24 weeks compared to baseline.
Time frame: 24 weeks
Changes in lipid profile at 24 weeks compared to baseline.
Time frame: 24 weeks
Changes in aspartate aminotransferase(AST)/alanine aminotransferase(ALT) at 24 weeks compared to baseline.
Time frame: 24 weeks
Changes in Body weight at 24 weeks compared to baseline.
Time frame: 24 weeks
Rate of side effects and discontinuation or change of drug after 24 weeks compared to baseline
Time frame: 24 weeks
Analysis of predictors of improvement in liver fibrosis after 24 weeks compared to baseline.
Time frame: 24 weeks
Analysis of predictors of improvement of fatty liver after 24 weeks compared to baseline.
Time frame: 24 weeks
Analysis of predictors of HbA1c improvement after 24 weeks compared to baseline.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
Related trials for Hepatitis B, Chronic
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
Seung Up Kim principal investigator
Severance Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pioglitazone 15 Mg Oral Tablet and Evogliptin 5mg in people with Hepatitis B, Chronic and Fibrosis, Liver, run by Seung Up Kim at 4 sites in South Korea.
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 5 inclusion and 19 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 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Liver Stiffness Measurement at 24 weeks compared to baseline. (time frame: 24 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 26 Jul 2022.