Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

NCT01788371 | Completed Phase 4

• 1 other identifier: 2011.6
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis B Infection; Chronic Infection; Viremia

Outcome Measures

Primary Outcomes (2)

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

  perinatal to 28 weeks after infant delivery

• Its efficacy in the reduction of HBV vertical transmission rate

  perinatal to 28 weeks after infant delivery

Secondary Outcomes (1)

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

  perinatal to 28 weeks of postpartum

Study Arms (3)

No antiviral arm

NO INTERVENTION

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

Lamivudine

EXPERIMENTAL

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

Drug: Lamivudine

Telbivudine

EXPERIMENTAL

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

Drug: Telbivudine

Interventions

Telbivudine DRUG

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

Telbivudine

Lamivudine DRUG

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

Lamivudine

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hua Zhang: lead
• Icahn School of Medicine at Mount Sinai: collaborator

MeSH Terms

Conditions

Hepatitis B; Persistent Infection; Viremia

Interventions

Telbivudine; Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine; Dideoxynucleosides

Study Officials

• Hua Zhang, MD

  Beijing YouAn Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 11, 2013
• Study Start: March 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: July 30, 2013

Record last verified: 2013-07