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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01488526
First Posted: December 8, 2011
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
New Discovery LLC
  Purpose

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.

Condition Intervention Phase
Hepatitis B Infection Chronic Infection Viremia Drug: TDF treatment Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Tenofovir Disoproxil Fumarate in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus in Highly Viremic Mothers

Resource links provided by NLM:


Further study details as provided by New Discovery LLC:

Primary Outcome Measures:
  • 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 ]
  • 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 Outcome Measures:
  • 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) ]
  • 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) ]
  • 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. ]

Enrollment: 200
Actual Study Start Date: March 1, 2012
Estimated Study Completion Date: October 28, 2017
Primary Completion Date: April 28, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control arm: HBIG & vaccine for infants
Provide standard of care to mothers and standard immunoprophylaxis to their infants
Experimental: TDF treatment arm
tenofovir from 30-32 weeks of pregnancy to the week 4 of postpartum for mothers and standard immunoprophylaxis to their infants
Drug: TDF treatment
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 Name: Viread, Tenofovir, TDF, Hepatitis B-IgG, Hepatitis B vaccine

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

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488526


Locations
China, Chongqing
Southwest Hospital
Chongqing, Chongqing, China, 400038
China, Hebei
The Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China, 050021
China, Henan
Nanyang Central Hospital
Nanyang, Henan, China, 473000
China, Jiangsu
The Second Affiliated Hospital of the Southeast University
Nanjing, Jiangsu, China, 210003
China, Jilin
Hepatobiliary Disease Hospital of Jilin Province
Chang Chun, Jilin, China, 130062
Sponsors and Collaborators
New Discovery LLC
Gilead Sciences
Investigators
Study Chair: Calvin Q Pan, MD Leading Principle Investigator, Division of Gastroenterology and Hepatology, NYU Langone Medical Center, New York
Study Director: Zhongping Duan, MD Capital Medical University
Principal Investigator: Shuqin Zhang, MD Hepatobiliary Disease Hospital of Jilin Province, Jilin, China
Principal Investigator: Erhei Dai, MD The Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei, China
Principal Investigator: Guorong Han, MD The Second Affiliated Hospital of the Southeast University, Nanjing, China
Principal Investigator: Huaihong Zhang, MD Nanyang Central Hospital, Nanyang, Henan, China
Principal Investigator: Yuming Wang, MD Southwest Hospital, Chongqing, Chongqing, China
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New Discovery LLC
ClinicalTrials.gov Identifier: NCT01488526     History of Changes
Other Study ID Numbers: IN-US 174-0174
First Submitted: November 30, 2011
First Posted: December 8, 2011
Last Update Posted: June 16, 2017
Last Verified: June 2017

Keywords provided by New Discovery LLC:
Hepatitis B
Vertical transmission
Pregnancy
Antiviral treatment

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis B
Viremia
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Vaccines
Tenofovir
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents