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Clinical study on the efficacy and safety of telbivudine for interrupting mother-to-child transmission of hepatitis B virus (HBV) in pregnant women

Clinical study on the efficacy and safety of telbivudine for interrupting mother-to-child transmission of hepatitis B virus (HBV) in pregnant women

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-16008318
Enrollment
Unknown
Registered
2016-04-19
Start date
2011-09-01
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 Telbivudine:LdT treatment (600 mg/day) from 28th. week of pregnancy until the delivery day, in case of confirmed CHB during pregnancy, they continued to use LdT after delivery according t
the group of anti-hepatis B immunoglobulin(HBIG):HBIG (200 IU dose once) was administered by intramuscular injection three times at the 28th., 32th., and 36th. gestational weeks.

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. The pregnant women had serum HBV DNA load higher than 6log10 copies/mL and positive serum HBsAg and HBeAg before the treatment; 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. 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 ContactYoupeng 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