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Cohort study on Tenofovir and Telbivudine in preventing mother-to-infant transmission of hepatitis B virus in pregnant women with high viremia

Cohort study on Tenofovir and Telbivudine in preventing mother-to-infant transmission of hepatitis B virus in pregnant women with high viremia

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-16008331
Enrollment
Unknown
Registered
2016-04-21
Start date
2015-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

chronic hepatitis B

Interventions

the group of tenofovir:Tenofovir (300mg) was taken every day from 28th-32nd weeks of pregnancy to the delivery day
the group of Telbivudine:Telbivudine (600mg) was taken every day from 28th-32nd weeks of pregnancy to the delivery day

Sponsors

the first Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Before the 28th-32nd week of gestation, the pregnant women had serum HBV DNA load higher than 6log10 copies/mL(2.0*10^5 IU/mL),normal liver function and positive serum HBsAg and HBeAg; 2. Ultrasound measurements performed during the 2nd. trimester showed no structural anomalies of the fetus without threatened abortion; 3. No alcohol/ smoking abuse or history; 4. No hypertensive disorders and diabetes mellitus before pregnancy.

Exclusion criteria

Exclusion criteria: 1. The pregnant women had other viral diseases or complications (such as hepatitis A, C, D, E and HIV infection); 2. The pregnant women had serious hepatic diseases,liver cirrhosis and or hepatic carcinoma and so on; 3. other drugs (such as immunologic drugs,cytotoxic drugs or steroids) were taken during the period of pregnancy; 4. Anti-HBV drugs were taken before pregnancy and in Early-middle stage of pregnancy; 5. Husband with HBV infection.

Design outcomes

Primary

MeasureTime frame
serum marker for heptitis B;the level of HBV-DNA;serum biochemical test;Biometric data of the fetus under the ultrasound measurement;biometric data of the newborn;

Countries

China

Contacts

Public ContactYou-Peng Chen

Department of Infectious Diseases, the first Affiliated Hospital of Jinan University

youpeng.chen@163.com+86 13710675157

Outcome results

None listed

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