Using dapagliflozin to prevent liver complications in patients with chronic hepatitis B and diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a five-year, double-blinded, randomized study comparing dapagliflozin to a placebo in patients suffering from chronic hepatitis B and diabetes mellitus or impaired fasting glucose with compensated advanced chronic liver disease. A total of 412 subjects will be recruited and randomly assigned to receive either dapagliflozin 10mg daily or a placebo for up to five years. Participants will be monitored at regular intervals for drug compliance, adverse events, and liver health assessments, including blood tests and transient elastography to evaluate fibrosis regression. The study aims to determine the efficacy of dapagliflozin in reducing liver complications associated with chronic hepatitis B.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with chronic hepatitis B on ETV, TDF or TAF monotherapy for at least 12 months.
2. 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.
3. Stable use of anti-diabetic drugs in the last three months.
4. 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)
5. Aged 18 years old or above.
6. Written informed consent obtained.

Exclusion Criteria:

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

Where it's running

• Prince of Wales Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Grace LH Wong, MD — Chinese University of Hong Kong
• Study coordinator: Angel ML Chim, MSc
• Email: angelchim@cuhk.edu.hk
• Phone: +85235054205

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.