The Study of Offspring development Safety of Telbivudine Prenatal Exposure

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OPC-16009018

Enrollment

Unknown

Registered

2016-08-13

Start date

2012-01-01

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

HBV

Interventions

LdT Treatment Group:None

non-AVT Group:None

Normal Control:None

Eligibility

Sex/Gender

Female

Age

20 Years to 35 Years

Inclusion criteria

Inclusion criteria: Pregnancy mothers with singleton neonates were enrolled during delivery in the Womens Hospital of Zhejiang University School of Medicine from January 2012 to September 2013. Mothers diagnosed with CHB and positive for HBsAg before pregnancy were defined as CHB mothers and were eligible for the study group. Neonates whose CHB mothers had been treated with only LdT were the exposed group (LdT group), and comparable neonates whose CHB mothers did not receive any anti-viral therapy were the non-exposed group (non-LdT group). Among the 30 mothers in the LdT group, 21 took LdT orally (600 mg once daily) (Novartis, Inc, Basel, Switzerland) during their entire pregnancy, and the rest 9 began in the second or third trimester. Normal controls were singleton neonates born in the same hospital during the same time period, and they were matched with the study group in gestational age and birth weight. All infants were given the HBV vaccine and HBIG immediately after birth and at one and six months.

Exclusion criteria

Exclusion criteria: Mothers with other hepatitis viruses (hepatitis A, C, D and E), syphilis or HIV were excluded as well as those who experienced severe pregnancy complications and delivery complications including gestational diabetes, gestational hypertension and intrahepatic cholestasis of pregnancy, intrauterine asphyxia and asphyxia neonatorum. CHB mothers treated with other antiviral drugs, such as lamivudine, adefovir and entecavir were excluded. Parents with genetic diseases or showing elevated creatine kinase (CK) were excluded.

Design outcomes

Primary

Measure	Time frame
creatine kinase;Bayley Scales of Infant Development;	—

Countries

China

Contacts

Public ContactHuang Hefeng

Women's Hospital, School of Medicine, Zhejiang University

Huanghefg@hotmail.com+86 18017310186

Outcome results

None listed

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