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Real-world observational study for the safety, efficacy and optimal withdrawal time of tenofovir alafenamide for the prevention of mother-to-child transmission of hepatitis B virus

Real-world observational study for the safety, efficacy and optimal withdrawal time of tenofovir alafenamide for the prevention of mother-to-child transmission of hepatitis B virus

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023803
Enrollment
Unknown
Registered
2019-06-12
Start date
2019-06-11
Completion date
Unknown
Last updated
2019-06-17

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 was administered at the 28th week of pregnancy and discontinued immediately after delivery.
Group 2:Tenofovir alafenamide was administered at the 28th week of pregnancy and discontinued one month after delivery.
Group 3:Tenofovir alafenamide was administered at the 28th week of pregnancy and discontinued three month after delivery.

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 womon; 2. Aged 20-40 years; 3. Diagnosed with HBeAg positive chronic hepatitis B virus infection.

Exclusion criteria

Exclusion criteria: 1. Comorbided with cirrhosis and/or hepatocellular carcinoma; 2. Coinfected with other hepatotropic virus (such as hepatitis C virus, et al);comorbided with alcoholic liver diseases,fatty liver diseses, autoimmune liver hepatitis, drug-induced liver injury and genetic liver diseases; 3. Comorbided with systemic disorders (such as hypertension,diabetes and human immunodeficiency virus infection, et al); 4. Comorbided with psychiatric disorders and psychological diseases.

Design outcomes

Primary

MeasureTime frame
Safety of tenofovir alafenamide for mothers and infants;Successful rate of prevention for mother-to-child transmission of hepatitis B virus;Withdrawal time of tenofovir alafenamide;

Countries

China

Contacts

Public ContactQinglei Zeng

The First Affiliated Hospital of Zhengzhou University

zengqinglei2009@163.com+86 15838120512

Outcome results

None listed

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