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Completed

NCT Number: NCT01743079

Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B

The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases Complication DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Late Pregnancy Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Transmission Virus Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Beijing YouAn Hospital

Beijing, Beijing Municipality, 100069, China

About this study

This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA > 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 20-40 years old
  • HBsAg, HBeAg positive and HBV DNA >6 log10 copies/ml
  • Gestational age: 26-28 weeks with normal fetus
  • Willing to consent for the study

Exclusion criteria

  • Elevated ALT
  • Antiviral treatment experience patients
  • Co-infection with HAV, HCV,HDV, HIV
  • Concurrent treatment with immune modulators, cytotoxic drugs, or steroids
  • Clinical signs of threatened miscarriage in early pregnancy
  • Clinical evidence of cirrhosis and/or hepatocellular carcinoma

Treatment and study plan

telbivudine

Drug

LdT 600mg QD

Other names: LdT

Lamivudine

Drug

LAM 100mg QD

Other names: LAM

Primary outcomes

  1. Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child

    Time frame: From gestation week 26 to postpartum week 52

Secondary outcomes

  1. percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion

    Time frame: From gestation week 26 to pastpartume week 52

Sponsors and collaborators

Lead sponsor

Beijing YouAn Hospital

Other

Collaborators

  • New Discovery LLC

Registry information

Official study title

The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2012
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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