Clinical Trials Logo
  1. Home
  2. HBV
  3. NCT01637844

Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV

HBV Clinical Trial

Official title:
Telbivudine in the Third Trimester of Pregnancy to Prevent Mother-to-infant Transmission of HBV

Clinical Trial Summary

Infants of hepatitis B virus (HBV)-infected mothers with positive hepatitis B e antigen (HBeAg) have an increased risk of becoming infected with HBV. This study will determine whether telbivudine among both hepatitis B surface antigen (HBsAg) and HBeAg positive pregnant women during the third trimester, in addition to standard immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at preventing HBV infections in these infants.

Clinical Trial Description

Infants of HBV-infected mothers with positive HBeAg have an increased risk of becoming infected with HBV. Standard immunoprophylaxis against mother-to-infant transmission of HBV includes administration of hepatitis B immunoglobulin (HBIG) and hepatitis B vaccine; however, approximately 5-15% of the infants are not protected despite having received these preventive measures. It is reported that antiviral prophylaxis among HBV-infected pregnant women can reduce mother-to-infant transmission of HBV. However, more research is needed to obtain the definite conclusion. This study will determine whether telbivudine among HBsAg- and HBeAg-positive pregnant women during the third trimester, in addition to standard immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at preventing HBV infections in these infants. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01637844
Study type Interventional
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact
Status Completed
Phase Phase 4
Start date April 2012
Completion date October 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT05442437 - Clinical Study of hUC-MSCs Treating Decompensated Liver Cirrhosis With HBV Early Phase 1
Completed NCT04519710 - Specific Anti-HBV Vaccine Response After Vaccination in Patients Requiring Anti-CD20 Monoclonal Antibodies N/A
Recruiting NCT04562051 - Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients
Recruiting NCT04683341 - Tenofovir Alafenamide in HBV Related Decompensated Liver Phase 4
Active, not recruiting NCT02344680 - Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
Completed NCT02044068 - Hepatitis B Virus Vertical Transmission From HIV-HBV Co-infected Women N/A
Completed NCT03239353 - A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Entecavir Extended Release (XR) in Healthy Subjects Phase 1
Recruiting NCT04904835 - Access HBV Assays - European Union (EU) Clinical Trial Protocol -
Terminated NCT04059198 - Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic Treatment Naive Subjects Infected With Hepatitis B Virus Phase 2
Not yet recruiting NCT05293158 - Impact of Hepatitis B Immunoglobulins in Patients With Chronic Hepatitis B on Hepatocellular Carcinoma - a Proof of Concept Study N/A
Not yet recruiting NCT05028322 - Evaluation of Intradermal Hepatitis B Vaccine After IMIQUIMOD's Application, in Cirrhotics Who Did Not Respond to the Usual Vaccine Regimen Phase 2
Not yet recruiting NCT01556815 - Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma Phase 2
Completed NCT02312531 - Prevention for Mother-to-infant Transmission of HBV N/A
Recruiting NCT05786859 - The Efficacy and Safety of Rifaximin Treatment Early Phase 1
Recruiting NCT05951751 - The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM) N/A
Not yet recruiting NCT06307808 - Viral Immunity in Solid Organ Transplant Recipients: Monitoring Of The Response To Hepatitis B Booster Vaccination
Completed NCT03149627 - Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults
Recruiting NCT04886336 - The Impact of Tenofovir Alafenamide on Profiles of Body Weight and Metabolic Features in Chronic Hepatitis B Patients.
Recruiting NCT04568265 - A Clinical Study of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis B Phase 2
Terminated NCT02826018 - A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection Phase 1