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

This study has been completed.
Sponsor:
Collaborator:
New Discovery LLC
Information provided by (Responsible Party):
Hua Zhang, Beijing YouAn Hospital
ClinicalTrials.gov Identifier:
NCT01743079
First received: December 3, 2012
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis B
Late Pregnancy
Transmission
Complication
Drug: Telbivudine
Drug: Lamivudine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission

Resource links provided by NLM:


Further study details as provided by Beijing YouAn Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 700
Study Start Date: January 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telbivudine
Mother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis
Drug: Telbivudine
LdT 600mg QD
Other Name: LdT
Experimental: Lamivudine
Mother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis.
Drug: Lamivudine
LAM 100mg QD
Other Name: LAM
No Intervention: No antiviral treatment
Mother receives no antiviral treatment. Infant receives standard immunoprophylaxis

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Elevated ALT
  2. Antiviral treatment experience patients
  3. Co-infection with HAV, HCV,HDV, HIV
  4. Concurrent treatment with immune modulators, cytotoxic drugs, or steroids
  5. Clinical signs of threatened miscarriage in early pregnancy
  6. Clinical evidence of cirrhosis and/or hepatocellular carcinoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743079

Locations
China, Beijing
Beijing YouAn Hospital
Beijing, Beijing, China, 100069
Sponsors and Collaborators
Beijing YouAn Hospital
New Discovery LLC
Investigators
Study Director: Calvin Pan, MD Division of Liver Diseases, Mount Sinai School of Medicine, Flushing, NY
Principal Investigator: Hua Zhang, MD Beijing YouAn Hospital
  More Information

No publications provided by Beijing YouAn Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hua Zhang, Professor, Beijing YouAn Hospital
ClinicalTrials.gov Identifier: NCT01743079     History of Changes
Other Study ID Numbers: 20080810
Study First Received: December 3, 2012
Last Updated: July 29, 2013
Health Authority: China: Food and Drug Administration
China: Ethics Committee

Keywords provided by Beijing YouAn Hospital:
Telbivudine
Lamivudine
safety
efficacy
pregnancy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Lamivudine
Telbivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 29, 2014