Study of Antiretroviral Therapy to Prevent HBV Intrauterine Infection

NCT02719808 | Unknown

• 1 other identifier: XJTU1AHCR2014-018
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis B, Chronic

Keywords

Vertical infection transmission; Tenofovir

Outcome Measures

Primary Outcomes (2)

• deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum

  Check HBV-DNA in serum by ELISA in pregnant women. The measure unit is copies/mL

  up to 1 year

• deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum

  Check HBV-DNA in serum by quantitative PCR in pregnant women. The measure unit is copies/mL

  up to 1 year

Secondary Outcomes (8)

• the concentration of Interleukin 2 (IL-2)

  up to 1 year

• interferon-γ (IFN-γ)

  up to 1 year

• Interleukin 4 (IL-4)

  up to 1 year

• Interleukin 6 (IL-6)

  up to 1 year

• T cell ratio

  up to 1 year

Study Arms (5)

Tenofovir1

100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one week after delivery.

Drug: Tenofovir1

Tenofovir2

100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one month after delivery.

Drug: Tenofovir2

Tenofovir3

100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one week after delivery.

Drug: Tenofovir3

Tenofovir4

100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one month after delivery.

Drug: Tenofovir4

Group without any treatment

100 patients don't receive any blockade therapies

Interventions

Tenofovir1 DRUG

receive tenofovir （300mg/d）from （28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.

Tenofovir1

Tenofovir2 DRUG

receive tenofovir （300mg/d）from（28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.

Tenofovir2

Tenofovir3 DRUG

receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one month after delivery, it is the observational exposure.

Tenofovir3

Tenofovir4 DRUG

receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one week after delivery, it is the observational exposure.

Tenofovir4

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• pregnancy patients with HBeAg-negative or HBV-DNA\<106copies /ml

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (1)

• Gao F, Zhang WT, Lin YY, Wang WM, Xu N, Bai GQ. Early Start Of Tenofovir Treatment Achieves Better Viral Suppression In Pregnant Women With A High HBV Viral Load: A Real-World Prospective Study. Infect Drug Resist. 2019 Nov 7;12:3475-3484. doi: 10.2147/IDR.S228982. eCollection 2019.

  PMID: 31807036 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, placenta tissue of HBeAg-positive pregnant women

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guiqin Bai, M.D.;Ph.D.

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guiqin Bai, M.D.;Ph.D.

CONTACT

86-18991232517; baigq@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: March 25, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)