SGLT2i to Prevent of Liver Complications in Patients With CHB and Diabetes Mellitus
Recruiting
Phase 4
Interventional Study
Chronic Hepatitis B
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 412 (estimated)
- Sponsor
- Chinese University of Hong Kong · Other
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About This Trial
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 wi…
Trial Locations
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Eligibility Criteria
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 gluc…
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