RecruitingPhase 4NCT06364930

SGLT2i to Prevent of Liver Complications in Patients With CHB and Diabetes Mellitus

Sodium-glucose Co-transporter-2 Inhibitor (SGLT2i) to Prevent of Liver Complications in Patients With Chronic Hepatitis B and Diabetes Mellitus: a Double-blind, Randomised, Placebo-controlled Trial

Sponsor

Chinese University of Hong Kong

Enrollment

412 participants

Start Date

Mar 26, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Hepatitis B

Summary

This is a five-year, double blinded, randomised trial of dapagliflozin versus placebo in patients with chronic hepatitis B and DM or IFG complicated with compensated advanced chronic liver disease (cACLD). 412 subjects will be recruited. Subject will be randomly assigned to receive dapagliflozin 10mg daily or dapagliflozin placebo one tablet daily for up to 5 years. After randomization, subject will be followed up at month 3, month 6 and then 6-monthly until 60 months (follow up ± 4 weeks from scheduled clinic visit is allowed). At each visit, drug compliance, physical examination, observed or reported adverse events will be assessed. 10ml of blood will be taken at each visit and transient elastography to assess fibrosis regression will be performed at 60th month or at withdrawal visit. You are discouraged to use (pegylated)-interferon, any other NA including lamivudine, adefovir, and telbivudine, another SGLT2i Empagliflozin (Jardiance), Dapagliflozin + Metformin XR (Xigduo).

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Patients with chronic hepatitis B on ETV, TDF or TAF monotherapy for at least 12 months.
Known or newly diagnosed type 2 diabetes mellitus (T2D), defined as HbA1c ≥5.7% or fasting blood sugar ≥5.6 mmol/L, or random blood sugar ≥11.1 mmol/L, or 2 hours sugar after oral glucose tolerance test ≥7.8 mmol/L.
Stable use of anti-diabetic drugs in the last three months.
Presence of compensated advanced chronic liver disease (cACLD) with liver stiffness measurement \>10.0 kPa, or significant portal hypertension (spleen stiffness measurement \> 41.3 kPa), or presence any sign of portal hypertension (e.g. splenomegaly, ascites, varices)
Aged 18 years old or above.
Written informed consent obtained.

Exclusion Criteria11

Patients with hepatitis C virus (HCV) infection as indicated by a positive antibody to HCV (anti-HCV) serology test.
Patients with history of cirrhotic complications or hepatocellular carcinoma
Patients with organ transplantation
Patients receiving a SGLT2i
Contraindications to SGLT2i due to renal insufficiency (GFR \< 45 mL/min/1.73m2)
Poor glycaemic control with HbA1c \>9.0%
Use of multiple anti-diabetic drugs (3 or more)
Change in anti-diabetic drugs in the last three months.
Serious medical illnesses or malignancy
Age \< 18 years
No patient consents

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