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NCT Number: NCT01488526

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

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.

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Key information

Conditions

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

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Southwest Hospital, Chongqing, Chongqing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TDF treatment

Drug

About 100 mothers treated with tenofovir from 30-32 weeks of pregnancy to the week 4 of postpartum, then observed to the end of the study at post-partum week 28, paired infants received standard HBV prophylaxis.

Other names: Viread, Tenofovir, TDF, Hepatitis B-IgG, Hepatitis B vaccine

Primary outcomes

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

    Time frame: From the date of birth to age of 28 weeks

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

    Time frame: From the date of randomization until 28 weeks of postpartum.

Secondary outcomes

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

    Time frame: From the date of radomization to the time of delivery (upto 12 weeks from the radomization)

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

    Time frame: From the date of radomization to the time of delivery (about 8 - 10 weeks from the radomization)

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

    Time frame: From the date of randomization until 28 weeks of postpartum.

Sponsors and collaborators

Lead sponsor

New Discovery LLC

Industry

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2018
First posted
Dec 8, 2011
Registry last updated
Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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