NCT07533929

Incidence and Predictors of Elevated ALT in Postpartum CHB Mothers

Not yet recruiting Last updated 16 April 2026

What this trial tests

trial in Elevated Alanine Aminotransferase in 352 participants. Not yet recruiting.

Timeline

1 August 2026

Primary endpoint
31 December 2027

31 December 2029

Quick facts

Lead sponsor	The Third Affiliated Hospital of Guangzhou Medical University
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	352
Start date	1 August 2026
Primary completion	31 December 2027
Estimated completion	31 December 2029

Conditions studied

• Elevated Alanine Aminotransferase — all drugs for Elevated Alanine Aminotransferase →
• Postpartum Chronic Hepatitis B Mothers — all drugs for Postpartum Chronic Hepatitis B Mothers →

Sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Who can join

Adults 20 to 40, female only, with Elevated Alanine Aminotransferase or Postpartum Chronic Hepatitis B Mothers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

China currently has about 86 million people with chronic hepatitis B virus infection, and infections caused by mother-to-child transmission account for 40% to 50% of new hepatitis B infections. Domestic and international guidelines both recommend that for pregnant women with high viral loads at 24-28 weeks of gestation, oral antiviral therapy should be administered based on a balance of risks and benefits and informed consent, continuing until after delivery, which can significantly reduce the rate of HBV mother-to-child transmission. Studies have reported that antiviral drugs such as tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) can reduce mother-to-child transmission rates in pregnant women with hepatitis B.

It has been reported that among pregnant women with hepatitis B infection and high viral loads but no obvious hepatitis, the incidence of postpartum hepatitis ranges from 15% to 35%. Among pregnant women who received antiviral therapy during pregnancy, 36.3% developed postpartum hepatitis. In a multicenter prospective randomized controlled trial (RCT), Pan and colleagues observed that the proportion of mothers with elevated ALT levels postpartum was 45% for those treated with tenofovir disoproxil fumarate (TDF) during pregnancy versus 30% for those untreated. A large retrospective cohort study involving 4,236 hepatitis B mothers in China found that the rate of postpartum ALT elevation in chronic hepatitis B pregnant women who did not receive antiviral therapy during pregnancy was 28.27%. This study also identified independent risk factors for postpartum ALT elevation, including high viral load during pregnancy. The peak periods of ALT elevation occurred between 4-6 weeks and 9-12 weeks postpartum, showing a bimodal distribution.

To explore the differences in prognosis between groups that did and did not receive antiviral therapy, we will conduct a prospective cohort study to assess the incidence of postpartum ALT elevation in mothers with chronic hepatitis B and identify independent risk factors that can predict postpartum ALT elevation. Our data will help healthcare providers better manage pregnant women with chronic hepatitis B.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.