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

Sponsor
Chinese University of Hong Kong
Study ID
NCT06364930
Phase
PHASE4
Status
Recruiting
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Conditions

  • Chronic Hepatitis B

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Dapagliflozin 10mg Tab QD for 60 months.
  • Placebo 10mg Tab — DRUG
    Placebo 10mg Tab QD for 60 months.

Study Details

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).

Key Dates

Start date
Mar 26, 2024
Status verified
Mar 2026
Primary completion
Oct 31, 2030
Completion
Mar 30, 2031

Study Design

Enrollment
412 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin
    10mg QD for 60 months
  • Placebo Comparator: Placebo
    10mg QD for 60 months

Primary Outcome Measure

The primary endpoint is liver complications [ Time Frame: 60 months ]

Central Contacts

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