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

This study is currently recruiting participants.
Verified August 2013 by New Discovery LLC
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
New Discovery LLC
ClinicalTrials.gov Identifier:
NCT01488526
First received: November 30, 2011
Last updated: August 10, 2013
Last verified: August 2013
  Purpose

Immunoprophylaxis failure of Hepatitis B (HBV) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to HBeAg positive mothers with high levels of HBV DNA. Maternal HBV DNA > 6log10 copies/mL is the major risk for the mother-to-child transmission. Prior 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 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 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Tenofovir Disoproxil Fumarate in Late Pregnancy to Prevent Mother to Child Transmission of Hepatitis B Virus: A Multi-Center Prospective, Randomized, Open-Label Study

Resource links provided by NLM:


Further study details as provided by New Discovery LLC:

Primary Outcome Measures:
  • Assessment of the safety 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. ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure the number of patients with ALT normalization at the end of the study compared to the baseline [ Time Frame: From the date of randomization until 28 weeks of postpartum. ] [ Designated as safety issue: Yes ]
  • Measure maternal HBV DNA reduction during the study period when compared to the baseline [ Time Frame: From the date of randomization until 28 weeks of postpartum. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: HBIG, HB vaccine
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 post-partum; follow up will continue until post-partum of 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

Ages Eligible for Study:   20 Years to 35 Years
Genders 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
  • 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 or 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 ALT > or = 5 x ULN U/mL, or Total Bilirubin > or = 2, or GFR < 100, or Albumin < 25 g/L
  • evidence of fetal deformity by ultrasound examination
  • patient is participating other clinical study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488526

Contacts
Contact: Calvin Q Pan, MD +01-7188887728 cpan11355@yahoo.com
Contact: Frank Huang, MD +86-13533051208 frankhuangyujun@gmail.com

Locations
China, Chongqing
Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400038
Contact: Yuming Wang, MD    023-65334998    wym417@163.com   
Contact: Hongfei Huang, MD    13983068253    huanghongfei1987@126.com   
Principal Investigator: Yuming Wang, MD         
Sub-Investigator: Junnan Li, MD         
China, Hebei
The Fifth Hospital of Shijiazhuang Recruiting
Shijiazhuang, Hebei, China, 050021
Contact: Baoshen Zhu, MD    +86-13331389593    zhubaoshen138323@163.com   
Contact: Erhei Dai, MD    +86-13323119296    daieh2008@126.com   
Principal Investigator: Baoshen Zhu, MD         
Sub-Investigator: Erhei Dai, MD         
China, Henan
Nanyang Central Hospital Recruiting
Nanyang, Henan, China, 473000
Contact: Huaihong Zhang, MD    0377-61660525    zhang1958@126.com   
Contact: Li Zhang, MD    0377-61660523    zhangli870920@126.com   
Sub-Investigator: Huaihong Zhang, MD         
Principal Investigator: Yufeng Zhai, MD         
China, Jiangsu
The Second Affiliated Hospital of the Southeast University Recruiting
Nanjing, Jiangsu, China, 210003
Contact: Guorong Han, MD    +86-13851623507    hgr518@163.com   
Contact: Hongxiu Jiang, MD    +86-025-83626372      
Principal Investigator: Guorong Han, MD         
Sub-Investigator: Wei Zhao, MD         
China, Jilin
Hepatobiliary Disease Hospital of Jilin Province Recruiting
Chang Chun, Jilin, China, 130062
Contact: Shuqin Zhang, MD    +86-13894892233    Zhangshuqin2009@126.com   
Contact: Wen Jing Zhao, MD    +86-13234454220      
Principal Investigator: Shuqin Zhang, MD         
Sub-Investigator: Chang Han, MD         
Sponsors and Collaborators
New Discovery LLC
Gilead Sciences
Investigators
Study Chair: Calvin Q Pan, MD Division of Gastroenterology and Hepatology, NYU Langone Medical Center
Study Director: Zhongping Duan, MD Capital Medical University
Principal Investigator: Shuqin Zhang, MD Hepatobiliary Disease Hospital of Jilin Province, Jilin, China
Principal Investigator: Baoshen Zhu, 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: Yufeng Zhai, MD Nanyang Central Hospital, Nanyang, Henan, China
Principal Investigator: Yuming Wang, MD Southwest Hospital, Chongqing, Chongqing, China
Principal Investigator: Zheng Zeng, MD, PhD New Discovery LLC
  More Information

No publications provided

Responsible Party: New Discovery LLC
ClinicalTrials.gov Identifier: NCT01488526     History of Changes
Other Study ID Numbers: IN-US 174-0174
Study First Received: November 30, 2011
Last Updated: August 10, 2013
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
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
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 23, 2014