Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B W… (NCT05473806) | Clinical Trial Compass
UnknownPhase 4
Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes
South Korea28 participantsStarted 2020-09-18
Plain-language 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
Who can participate
Age range20 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* Patients treated with oral or parenteral corticosteroids chronically (\>14 consecutive days) within 8 weeks prior to screening
* Malnutrition, starvation, and debilitatin…
What they're measuring
1
Changes in Liver Stiffness Measurement at 24 weeks compared to baseline.