Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes Clinical Trial
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
| Verified date | October 2020 |
| Source | Yonsei University |
| Contact | Seung Up Kim |
| Phone | +82-2228-1982 |
| ksukorea[@]yuhs.ac | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The clinical study determines the effect of Evogliptin in patients with type 2 diabetes mellitus and chronic hepatitis B to confirm the improvement of hepatic fibrosis.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | May 2022 |
| Est. primary completion date | May 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Adultes between 20 and 80 years of age - Patients who satisfy the following conditions among chronic hepatitis B patients diagnosed with type 2 diabetes 1. Patients who are newly diagnosed as type 2 diabetes : 6.5% = HbA1c < 10.0% 2. Patients who are already diagnosed as type 2 diabetes: HbA1c < 10.0% - Patients who have significant liver fibrosis of at least 7 kPa in a hepaticity test using fibroscan - Patients who voluntarily signed the consent form after informed on the object, method, benefits and risks of the clinical study Exclusion Criteria: - Patients who were taking Pioglitazone or Evoglipitin medication or who took diabetes medication within 4 weeks at the time - Patients who meet the standard of alcoholic fatty liver (in excess of 210g per week for men and 140g per week for women over the last two years) - Liver cirrhosis patients with impaired liver function (CTP class B and C) - Patients who took drugs that can cause fatty liver (amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc.) - Patients with acute or chronic metabolic acidosis with or without coma and history of ketonic acid (within 24 weeks) - Allergic or hypersensitive to the target drug or its composition; - Patients treated with oral or non - oral corticosteroid treatment for chronic (more than 14 consecutive days) within 8 weeks prior to screening. - Poor nutrition, starvation, and debilitating conditions (including severe infections and severe injury patients before and after surgery) - Patients who are receiving radiation and chemotherapy for malignant tumors or patients who have been on chemotherapy or radiation treatment for less than two years. - Patients with heart failure in 24 weeks (class III to IV in NYHA classification) or unregulated arrhythmia. - Patients with acute cardiovascular disease in 12 weeks or less (e.g. unstable angina, myocardial infarction, routine ischemic seizures, cerebrovascular disease, coronary bypass surgery, or coronary artery interventions). - Patients with renal failure, chronic neuropathy (estimated glomerular filtration rate <60 mL/min/1.73 m2) or dialysis - Anemia patients whose Hb levels are less than 10.5g/dl - Women who are pregnant or breastfeeding - Patients who do not agree to use proper contraception during clinical trials only for women or men. - Patients who took medicines for clinical trials in other clinical trials within four weeks of document consent - Patients who are unable to participate in clinical trials on the judgment of other researchers - Patients who cannot read the consent form (e.g. illiteracy, foreigners, etc.) |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Gangnam Severance Hospital | Seoul | |
| Korea, Republic of | Samsung Hospital | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Yonsei Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days) | Changes in the Liver Stiffness measurement after 24 weeks (±7days) compared to Baseline within and between arms | Baseline | |
| Primary | Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days) | Changes in the Liver Stiffness measurement after 24 weeks (±7days) compared to Baseline within and between arms | Baseline to 24 weeks (±7days) | |
| Secondary | Changes from baseline CAP (Controlled Attenuation Parameter) at week 24 (±7days) within and between arms | Change from baseline at Week 24 (±7days) is defined as [(Baseline CAP value) - (Follow-up CAP value)] / (Baseline CAP value) * 100 (%) | 1) Baseline, 2) Baseline to 24 weeks (±7days) | |
| Secondary | Changes from baseline HbA1c at week 24 (±7days) within and between arms | Change from baseline at Week 24 (±7days) is defined as HbA1c at Week 24 (±7days) minus HbA1c at Week 0 | 1) Baseline, 2) Baseline to 24 weeks (±7days) | |
| Secondary | Changes from baseline Insulin at week 24 (±7days) within and between arms | Change from baseline at Week 24 (±7days) is defined as insulin at Week 24 (±7days) minus insulin at Week 0 | 1) Baseline, 2) Baseline to 24 weeks (±7days) | |
| Secondary | Changes from baseline lipid profile (total cholesterol, HDL, LDL, TG) at week 24 (±7days) within and between arms | Change from baseline at Week 24 (±7days) is defined as lipid profile (total cholesterol, HDL, LDL, TG) at Week 24 (±7days) minus lipid profile at Week 0 | 1) Baseline, 2) Baseline to 24 weeks (±7days) | |
| Secondary | Changes from baseline AST/ALT at week 24 (±7days) within and between arms | Change form baseline at Week 24 (±7days) is defined as the proportion of AST/ALT values who are normalized at Week 24 (±7days) | 1) Baseline, 2) Baseline to 24 weeks (±7days) | |
| Secondary | Changes from baseline Body weight at week 24 (±7days) within and between arms | Change from baseline at Week 24 (±7days) is defined as body weight at Week 24 minus body weight at Week 0 | 1) Baseline, 2) Baseline to 24 weeks (±7days) | |
| Secondary | Changes from baseline Liver fibrosis and fatty liver at week 24 (±7days) among the MRE+MRI PDFF enforcement arms within and between arms | Change from baseline at Week 24 (±7days) is defined by MRE+MRI PDFF | 1) Baseline, 2) Baseline to 24 weeks (±7days) | |
| Secondary | Proportions of adverse effects and drug interruptions or changes between baseline and week 24 (±7days) within and between arms | Compare between baseline at Week 24 (±7days) is defined as the occurrence rate of adverse events and drug interruptions or changes | 1) Baseline, 2) Baseline to 24 weeks (±7days) | |
| Secondary | Prognostic factor of the Improvement of Liver fibrosis between baseline and week 24 (±7days) within and between arms | Prediction Factor Analysis of the Improvement of Liver fibrosis after 24 (±7days) weeks compared to Baseline within and between arms | 1) Baseline, 2) Baseline to 24 weeks (±7days) | |
| Secondary | Prognostic factor of the Improvement of Fatty liver between baseline and week 24 (±7days) within and between arms | Prediction Factor Analysis of the Improvement of Fatty liver after 24 weeks (±7days) compared to Baseline within and between arms | 1) Baseline, 2) Baseline to 24 weeks (±7days) | |
| Secondary | Prognostic factor of the Improvement of HbA1 between baseline and week 24 (±7days) within and between arms | Prediction Factor Analysis of the Improvement of HbA1c after 24 weeks (±7days) compared to Baseline within and between arms | 1) Baseline, 2) Baseline to 24 weeks (±7days) |