Actively Recruiting
SGLT2i to Prevent of Liver Complications in Patients With CHB and Diabetes Mellitus
Led by Chinese University of Hong Kong · Updated on 2026-03-18
412
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
SGLT2i to Prevent of Liver Complications in Patients With CHB and Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with chronic hepatitis B on entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide monotherapy for at least 12 months
- Known or newly diagnosed type 2 diabetes mellitus defined by specific blood sugar or HbA1c criteria
- Stable use of anti-diabetic drugs in the last three months
- Presence of compensated advanced chronic liver disease with specified liver stiffness or signs of portal hypertension
- Age 18 years or older
- Written informed consent obtained
You will not qualify if you...
- Positive antibody to hepatitis C virus (HCV) infection
- History of cirrhotic complications or hepatocellular carcinoma
- Organ transplantation
- Current use of any SGLT2 inhibitor
- Renal insufficiency with GFR less than 45 mL/min/1.73m2
- Poor glycaemic control with HbA1c greater than 9.0%
- Use of three or more anti-diabetic drugs
- Change in anti-diabetic drugs in the last three months
- Serious medical illnesses or malignancy
- Age under 18 years
- Lack of patient consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
A
Angel ML Chim, MSc
CONTACT
G
Grace LH Wong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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