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Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus

Information source: New Discovery LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B Infection; Chronic Infection; Viremia

Intervention: TDF treatment (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: New Discovery LLC

Official(s) and/or principal investigator(s):
Calvin Q Pan, MD, Study Chair, Affiliation: Leading Principle Investigator, Division of Gastroenterology and Hepatology, NYU Langone Medical Center, New York
Zhongping Duan, MD, Study Director, Affiliation: Capital Medical University
Shuqin Zhang, MD, Principal Investigator, Affiliation: Hepatobiliary Disease Hospital of Jilin Province, Jilin, China
Erhei Dai, MD, Principal Investigator, Affiliation: The Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei, China
Guorong Han, MD, Principal Investigator, Affiliation: The Second Affiliated Hospital of the Southeast University, Nanjing, China
Huaihong Zhang, MD, Principal Investigator, Affiliation: Nanyang Central Hospital, Nanyang, Henan, China
Yuming Wang, MD, Principal Investigator, Affiliation: Southwest Hospital, Chongqing, Chongqing, China

Summary

Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to hepatitis B e antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA > 6log10 copies/mL (or >200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior observational studies have shown that antiviral therapy including lamivudine or telbivudine use during late pregnancy can safely reduce the rate of vertical transmission in this special population compared to untreated patients. Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study: 1. The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10 copies/mL (or > 200,000 IU/mL) during late pregnancy and infants. 2. Its efficacy in the reduction of HBV vertical transmission rate.

Clinical Details

Official title: Tenofovir Disoproxil Fumarate in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus in Highly Viremic Mothers

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

Primary outcome:

Measure the number of infants who have HBV infection at the age of 28 weeks

Assessment of the safety and tolerability of TDF, measure the number of participants and paired infants with adverse events

Secondary outcome:

Measure maternal HBV DNA reduction during the study period when compared to the baseline

percentage of mothers with sero-negativity or sero-conversion of HBsAg and/or HBeAg in each group for comparison

Detailed description: Eligible mothers will be randomized (1: 1) to either TDF-treated group or untreated group with about 100 subjects in each arm. The treatment group will receive TDF starting at week 30-32 of gestation until week 4 postpartum; follow up will continue until post-partum week 28 and infants age of 28 weeks. Untreated group will receive the standard of care with similar follow-up schedule as the treatment group.

Eligibility

Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- documented CHB infection with HBsAg positive > 6 months

- HBeAg+ CHB pregnant women

- gestational age between 30-32 weeks

- HBV DNA > 6 log10 copies/mL (or >200,000 IU/mL)

- both mother and father of the child are willing to consent for the study

Major Exclusion Criteria:

- co-infection with hepatitis A, C, D, E, HIV-1 or sexually transmitted disease (STD)

- decompensated liver disease or significant co-morbidity

- history of abortion, or diagnosis of fetal defect, or congenital malformation in

prior pregnancy

- antiviral used within six months prior to this pregnancy, or history of renal or

tubular function impairment due to adefovir.

- requirement for other medication during pregnancy to manage other chronic disease(s)

or concurrent treatment with immune-modulators, cytotoxic drugs, or steroids

- the biological father of the child had CHB

- clinical signs of threatened miscarriage in early pregnancy

- evidence of hepatocellular carcinoma

- maternal alanine aminotransferase (ALT) > or = 5 x upper limit of normal (U/mL), or

Total Bilirubin > or = 2, or glomerular filtration rate (GFR) < 100, or Albumin < 25 g/L

- evidence of fetal deformity by ultrasound examination

- patient is participating other clinical study

Locations and Contacts

Southwest Hospital, Chongqing, Chongqing 400038, China

The Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei 050021, China

Nanyang Central Hospital, Nanyang, Henan 473000, China

The Second Affiliated Hospital of the Southeast University, Nanjing, Jiangsu 210003, China

Hepatobiliary Disease Hospital of Jilin Province, Chang Chun, Jilin 130062, China

Additional Information

Starting date: December 2011
Last updated: June 7, 2015

Page last updated: August 23, 2015

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