NCT06364930RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 412 (estimated)
- First submitted
- 8 Apr 2024
- Start date
- 26 Mar 2024
- Primary completion date
- 31 Oct 2030
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Hepatitis B
- NCT number
- NCT06364930
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 412
- From 26 Mar 2024 to the primary completion date, 31 Oct 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with organ transplantation
- Patients receiving a SGLT2i
- Use of multiple anti-diabetic drugs (3 or more)
- Change in anti-diabetic drugs in the last three months.
Other illness
- 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
- Serious medical illnesses or malignancy
Lab values
- Contraindications to SGLT2i due to renal insufficiency (GFR \< 45 mL/min/1.73m2)
- Poor glycaemic control with HbA1c \>9.0%
Age
- Age \< 18 years
Other
- No patient consents
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.