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Trial record 159 of 314 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Study of Antiretroviral Therapy to Prevent HBV Intrauterine Infection

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by First Affiliated Hospital Xi'an Jiaotong University
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier:
NCT02719808
First received: March 6, 2016
Last updated: September 23, 2016
Last verified: September 2016
  Purpose
500 pregnant patients with HBeAg-positive and HBV-DNA> 106copies /ml who will do their pregnant check in the First Affiliated Hospital of Xi'an Jiaotong University will be enrolled into the study. There will be five groups to be observed. Four groups are taking tenofovir to prevent intrauterine infection during pregnancy. One group is not taking any anti-HBV virus treatments.The clinical value and effectiveness of tenofovir on blocking HBV intrauterine infection will be evaluated; The HBV-DNA infection status of placenta tissue will be checked by quantitative Polymerase Chain Reaction (PCR) to assess the changes of HBV-DNA of placenta after treating with tenofovir and explore the mechanism of tenofovir blocking HBV intrauterine infection. The safety of Tenofovir will be assessed as well.

Condition Intervention
Hepatitis B, Chronic Drug: Tenofovir1 Drug: Tenofovir2 Drug: Tenofovir3 Drug: Tenofovir4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cohort Study of Tenofovir on Blocking HBV Intrauterine Infection

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital Xi'an Jiaotong University:

Primary Outcome Measures:
  • deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum [ Time Frame: up to 1 year ]
    Check HBV-DNA in serum by ELISA in pregnant women. The measure unit is copies/mL

  • deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum [ Time Frame: up to 1 year ]
    Check HBV-DNA in serum by quantitative PCR in pregnant women. The measure unit is copies/mL


Secondary Outcome Measures:
  • the concentration of Interleukin 2 (IL-2) [ Time Frame: up to 1 year ]
    the concentration of Interleukin 2 (IL-2)in serum of pregnant women, U/mL

  • interferon-γ (IFN-γ) [ Time Frame: up to 1 year ]
    the concentration of interferon-γ (IFN-γ) in serum of pregnant women,U/mL

  • Interleukin 4 (IL-4) [ Time Frame: up to 1 year ]
    the concentration of Interleukin 4 (IL-4)in serum of pregnant women, U/mL

  • Interleukin 6 (IL-6) [ Time Frame: up to 1 year ]
    the concentration of Interleukin 6 (IL-6)in serum of pregnant women,U/mL

  • T cell ratio [ Time Frame: up to 1 year ]
    T cell ratio in serum is measured by follow cytometry in pregnant women

  • HBV-DNA of babies [ Time Frame: when the baby is 7-month-old ]
    Check HBV-DNA by ELISA and quantitative PCR. The measure unit is copies/mL. All babies who used tenofovir will be tested when he is 7-month-old, in order to make sure whether they have infection during pregnant period.

  • hepatitis B e-antigen (HBeAg) [ Time Frame: up to 1 year ]
    check HBeAg in serum of pregnant women.the measure unit is PEIU/mL

  • HBV-DNA in placenta tissue [ Time Frame: the date of delivery ]
    Check HBV-DNA of placenta tissue by quantitative PCR. The measure unit is copies/mL.


Biospecimen Retention:   Samples Without DNA
Blood, placenta tissue of HBeAg-positive pregnant women

Estimated Enrollment: 500
Study Start Date: March 2015
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tenofovir1
100 patients receive tenofovir (300mg/d)from (28±2) weeks of pregnancy to one week after delivery.
Drug: Tenofovir1
receive tenofovir (300mg/d)from (28±2)weeks of pregnancy to one month after delivery, it is the observational exposure.
Tenofovir2
100 patients receive tenofovir (300mg/d)from (28±2) weeks of pregnancy to one month after delivery.
Drug: Tenofovir2
receive tenofovir (300mg/d)from(28±2)weeks of pregnancy to one month after delivery, it is the observational exposure.
Tenofovir3
100 patients receive tenofovir (300mg/d)from (20±2)weeks of pregnancy to one week after delivery.
Drug: Tenofovir3
receive tenofovir (300mg/d)from (20±2)weeks of pregnancy to one month after delivery, it is the observational exposure.
Tenofovir4
100 patients receive tenofovir (300mg/d)from (20±2)weeks of pregnancy to one month after delivery.
Drug: Tenofovir4
receive tenofovir (300mg/d)from (20±2)weeks of pregnancy to one week after delivery, it is the observational exposure.
Group without any treatment
100 patients don't receive any blockade therapies

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pregnant women with HBeAg-positive and HBV-DNA>106copies/ml from the out-patient department of First Affiliated Hospital of Xi'an Jiaotong University
Criteria

Inclusion Criteria:

  • pregnancy patients with HBeAg-positive and HBV-DNA> 106copies /ml

Exclusion Criteria:

  • pregnancy patients with HBeAg-negative or HBV-DNA<106copies /ml
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02719808

Contacts
Contact: Guiqin Bai, M.D.;Ph.D. 86-18991232517 baigq@126.com

Locations
China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Guiqin Bai, M.D.;Ph.D.    86-18991232517    baigq@126.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
Principal Investigator: Guiqin Bai, M.D.;Ph.D. First Affiliated Hospital Xi'an Jiaotong University
  More Information

Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02719808     History of Changes
Other Study ID Numbers: XJTU1AHCR2014-018
Study First Received: March 6, 2016
Last Updated: September 23, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Vertical infection transmission
Tenofovir

Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Hepatitis
Hepatitis, Chronic
Infection
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Liver Diseases
Digestive System Diseases
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 20, 2017