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

Primary Purpose

Chronic Hepatitis B, Late Pregnancy, Transmission

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Telbivudine
Lamivudine
Sponsored by
Beijing YouAn Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Hepatitis B focused on measuring Telbivudine, Lamivudine, safety, efficacy, pregnancy

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing YouAn Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Telbivudine

Lamivudine

No antiviral treatment

Arm Description

Mother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis

Mother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis.

Mother receives no antiviral treatment. Infant receives standard immunoprophylaxis

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
December 3, 2012
Last Updated
July 29, 2013
Sponsor
Beijing YouAn Hospital
Collaborators
New Discovery LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01743079
Brief Title
Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B
Official Title
The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing YouAn Hospital
Collaborators
New Discovery LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B, Late Pregnancy, Transmission, Complication
Keywords
Telbivudine, Lamivudine, safety, efficacy, pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telbivudine
Arm Type
Experimental
Arm Description
Mother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis
Arm Title
Lamivudine
Arm Type
Experimental
Arm Description
Mother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis.
Arm Title
No antiviral treatment
Arm Type
No Intervention
Arm Description
Mother receives no antiviral treatment. Infant receives standard immunoprophylaxis
Intervention Type
Drug
Intervention Name(s)
Telbivudine
Other Intervention Name(s)
LdT
Intervention Description
LdT 600mg QD
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Other Intervention Name(s)
LAM
Intervention Description
LAM 100mg QD
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Calvin Pan, MD
Organizational Affiliation
Division of Liver Diseases, Mount Sinai School of Medicine, Flushing, NY
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hua Zhang, MD
Organizational Affiliation
Beijing YouAn Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing YouAn Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25187919
Citation
Zhang H, Pan CQ, Pang Q, Tian R, Yan M, Liu X. Telbivudine or lamivudine use in late pregnancy safely reduces perinatal transmission of hepatitis B virus in real-life practice. Hepatology. 2014 Aug;60(2):468-76. doi: 10.1002/hep.27034.
Results Reference
derived

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

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