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Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

Primary Purpose

Hepatitis B Infection, Chronic Infection, Viremia

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Telbivudine

Lamivudine

About this trial

This is an interventional prevention trial for Hepatitis B Infection

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

HBeAg+CHB pregnant woman gestational age 28 weeks HBV-DNA>log10 copies/ml

Exclusion Criteria:

co-infection with hepatitis A,C,D,E or HIV evidence of hepatocellular carcinoma decompensated liver disease or significant co-morbidity concurrent treatment with immune-modulators,cytotoxic drugs,or steroids clinical signs of threatened miscarriage in early prenancy evidence of fetal deformity by ultrasound examination the biological father of the child had CHB

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

No antiviral arm

Lamivudine

Telbivudine

Arm Description

provide standard of care to mothers and standard immunoprophylaxis to their infants

lamivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants

Telbivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants

Outcomes

Primary Outcome Measures

The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants

Its efficacy in the reduction of HBV vertical transmission rate

Secondary Outcome Measures

Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg

Full Information

NCT ID

NCT01788371

First Posted

February 7, 2013

Last Updated

July 29, 2013

Sponsor

Hua Zhang

Collaborators

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT01788371

Brief Title

Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

Official Title

Nucleoside Analogue in Late Preganancy to Prevent Vertical Transmission of Hepatitis B Virus

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hua Zhang

Collaborators

Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.

Detailed Description

Telbivudine and Lamivudine,a preganancy category B medication,reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients with few adverse effects.Two aspects on the drug use in pregnancy will be evaluated prospectively in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B Infection, Chronic Infection, Viremia

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

No antiviral arm

Arm Type

No Intervention

Arm Description

provide standard of care to mothers and standard immunoprophylaxis to their infants

Arm Title

Lamivudine

Arm Type

Experimental

Arm Description

lamivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants

Arm Title

Telbivudine

Arm Type

Experimental

Arm Description

Telbivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants

Intervention Type

Drug

Intervention Name(s)

Telbivudine

Intervention Description

About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun

Intervention Type

Drug

Intervention Name(s)

Lamivudine

Intervention Description

About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum

Primary Outcome Measure Information:

Title

The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants

Time Frame

perinatal to 28 weeks after infant delivery

Title

Its efficacy in the reduction of HBV vertical transmission rate

Time Frame

perinatal to 28 weeks after infant delivery

Secondary Outcome Measure Information:

Title

Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg

Time Frame

perinatal to 28 weeks of postpartum

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HBeAg+CHB pregnant woman gestational age 28 weeks HBV-DNA>log10 copies/ml Exclusion Criteria: co-infection with hepatitis A,C,D,E or HIV evidence of hepatocellular carcinoma decompensated liver disease or significant co-morbidity concurrent treatment with immune-modulators,cytotoxic drugs,or steroids clinical signs of threatened miscarriage in early prenancy evidence of fetal deformity by ultrasound examination the biological father of the child had CHB

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hua Zhang, MD

Organizational Affiliation

Beijing YouAn Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

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