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Safety and Efficacy of Tenofovir Alafenamide to Prevent Hepatitis B Virus Transmission in Pregnant Women with High Viral Load: A Real World, Retrospective, Observational Study

Safety and Efficacy of Tenofovir Alafenamide to Prevent Hepatitis B Virus Transmission in Pregnant Women with High Viral Load: A Real World, Retrospective, Observational Study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024618
Enrollment
Unknown
Registered
2019-07-19
Start date
2019-07-19
Completion date
Unknown
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B

Interventions

Group 1:Tenofovir alafenamide, HBV vaccine, HBIG
Group 2:Tenofovir alafenamide, HBV vaccine, HBIG

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) Pregnant women; (2) HBsAg and HBeAg positivity for more than 6 months; (3) HBV DNA positive.

Exclusion criteria

Exclusion criteria: (1) With comorbidity of cirrhosis and/or hepatocellular carcinoma; (2) Coinfection with human immunodeficiency virus (HIV) or other hepatotropic virus (such as hepatitis C virus, et al); (3) With comorbidity of alcoholic liver diseases, fatty liver diseses, autoimmune liver hepatitis, drug-induced liver injury and genetic liver diseases; (4) With comorbidity of systemic disorders of the mothers (such as hypertension and diabetes, et al) or fetus; (5) A history of abortion, pregnancy loss, or congenital malformation in a previous pregnancy; (6) With comorbidity of psychiatric disorders and psychological disorders; (7) Severe abnormality of peripheral blood cell counts.

Design outcomes

Primary

MeasureTime frame
Rate of mother-to-child transmission;Birth defect;

Secondary

MeasureTime frame
The percentage of mothers who had an HBV DNA level of less than 200,000 IU per milliliter at delivery;Maternal HBeAg-seroconverion rate;Maternal ALT elevation or normalization rate;Maternal renal function;Maternal bone marker;Newborn's Apgar score;Newborn's growth parameters;

Countries

China

Contacts

Public ContactQing-Lei Zeng, Zu-Jiang Yu

The First Affiliated Hospital of Zhengzhou University

zengqinglei2009@163.com+86 15838120512, +86 18603710022

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026