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Telbivudine to prevent mother-to-infant transmission of HBV in early and mid pregnancy

Telbivudine to prevent mother-to-infant transmission of HBV in early and mid pregnancy

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-16007899
Enrollment
Unknown
Registered
2016-01-25
Start date
2009-01-01
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

Group A: treated with telbivudine from12 weeks of gestation,Telbivudine was discontinued at postpartum 12 weeks.
group B : treated with telbivudine from20 to 28 weeks of gestation,Telbivudine was discontinued at postpartum 12 weeks.
Group C:wasn’t given telbivudine treatment

Sponsors

Qingdao Chengyang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. aged 20 to 35 years; 2. 12 weeks or 20-28 weeks of gestation; 3. patients with HBsAg-positive, HBeAg-positive, HBV DNA >=1.0*10^7 copies/ml; 4. alanine aminotransferase (ALT): 40 to 400 U/L; 5. good compliance.

Exclusion criteria

Exclusion criteria: 1. coinfection with other viruses during pregnancy: such as hepatitis A, C, D, E, human immunodeficiency virus, syphilis, toxoplasma gondii, rubella virus, cytomegalovirus, or simple herpesvirus infection; 2. The use of other antiviral drugs, immunosuppressive, cytotoxic drugs or corticosteroids during pregnancy ; 3. fetal deformity suggested by ultrasound examination; 4. genetic diseases; 5. gestational diabetes; serious respiratory, urinary, neurological comorbidity or combined with serious gastrointestinal diseases which affect drug absorption.

Design outcomes

Primary

MeasureTime frame
serum levels of HBV DNA;ALT level;HBsAg positive rate;gestational age;body weight;head circumference;Apgar score;

Secondary

MeasureTime frame
the age of pregnant women;the disease duration years of pregnant women;the gravidity times and gestational of pregnent women;

Countries

China

Contacts

Public ContactSUN WH
sunty2009@126.com+86 13396399678

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 10, 2026