Health TrialsbyHealthPanel

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

ConditionChronic Hepatitis B
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

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 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Patients with organ transplantation

Patients receiving a SGLT2i

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin 10mg Tab

    Drug

    Dapagliflozin 10mg Tab QD for 60 months.

  • Placebo 10mg Tab

    Drug

    Placebo 10mg Tab QD for 60 months.

Treatment groups

412 Participants
are divided into 2 treatment groups
Group A: DapagliflozinActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The primary endpoint is liver complications

defined as HCC and any cirrhotic complications, namely ascites, spontaneous bacterial peritonitis (SBP), variceal bleeding, hepatic encephalopathy, and/or hepatorenal syndrome (HRS).

Time frame
60 months

Secondary outcomes

1

Cardiovascular complications

defined as cardiovascular deaths, hospitalizations for heart failure, and urgent heart failure

Time frame
60 months
2

change in liver stiffness measurement

measured with transient elastography Unabbreviated scale title of kPa is kilopascals Minimum 0 kPa Maximum 80 kPa Higher scores mean a worse outcome

Time frame
60 months
3

change anthropometric parameters (body weight)

body weight

Time frame
60 months
4

change anthropometric parameters (waist-hip ratio)

waist-hip ratio

Time frame
60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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