The Incidence of Postpartum Hepatitis in Pregnant Women With Chronic Hepatitis B Virus Infection
Primary Purpose
Chronic Hepatitis B
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tenofovir Disoproxil Fumarate
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring antiviral treatment, hepatitis B virus, pregnant woman, Postpartum hepatitis
Eligibility Criteria
Inclusion Criteria:
- Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA > 106 copies/ml
- healthy Pregnant women with HBsAg(-), HBeAg(-)
Exclusion Criteria:
- Active consumption of alcohol and/or drugs
- Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus, HIV, etc.
- History of autoimmune hepatitis
- Psychiatric disease
- Evidence of neoplastic diseases of the liver
- without gestational hypertension, premature rupture of membranes, antepartum haemorrhage diseases or amniotic fluid piercing history during pregnancy.
Sites / Locations
- Beijing Ditan hospital,Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
experimental group
Arm Description
In this group, pregnant women with HBsAg/HBeAg positive and HBV DNA > 106 copies/ml don not use any antiviral drugs during pregnancy.healthy Pregnant women with HBsAg(-), HBeAg(-)
pregnant women with HBsAg/HBeAg positive and HBV DNA > 106 copies/ml start to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation and drug withdrawal after delivery immediately, and drug withdrawal in the 6 weeks after delivery.
Outcomes
Primary Outcome Measures
The incidence rate of hepatitis flare after drug withdrawal in maternal postpartum
ALT > 3 times the upper limit of normal
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03214302
Brief Title
The Incidence of Postpartum Hepatitis in Pregnant Women With Chronic Hepatitis B Virus Infection
Official Title
The Incidence of Postpartum Hepatitis in Pregnant Women With High HBVDNA Loads
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (undefined)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Ditan Hospital
4. Oversight
5. Study Description
Brief Summary
The majority of childbearing age women with hepatitis B virus infection were still in the immune tolerance period. Our recent research had shown that most puerperae after delivery had elevated ALT level. However, there is no withdrawal time recommendations after childbirth at present.Through the study of hepatitis occurrence after delivery and drug withdrawal, the investigators explore the withdrawal time of antiviral treatment during pregnancy.
Detailed Description
Most of childbearing age women with hepatitis B virus infection were still in the immune tolerance period. Our recent research had shown that most puerperae after delivery had elevated ALT level, and 11.5% of patients with HBV DNA positive would lead to deterioration of liver function. Meanwhile, the highest peak of ALT level could occur in 2 weeks after delivery, then it would dropped to a low point in 4-5 weeks. However, there is no withdrawal time recommendations after childbirth at present.The aim of our study is to investigate the changes of serological indexes, the changing rule of the liver function, hepatitis status, and its correlation with antiviral therapy in pregnant women with HBV infection after delivery, and then explore the withdrawal time of antiviral treatment during pregnancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
antiviral treatment, hepatitis B virus, pregnant woman, Postpartum hepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
560 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
In this group, pregnant women with HBsAg/HBeAg positive and HBV DNA > 106 copies/ml don not use any antiviral drugs during pregnancy.healthy Pregnant women with HBsAg(-), HBeAg(-)
Arm Title
experimental group
Arm Type
Experimental
Arm Description
pregnant women with HBsAg/HBeAg positive and HBV DNA > 106 copies/ml start to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation and drug withdrawal after delivery immediately, and drug withdrawal in the 6 weeks after delivery.
Intervention Type
Drug
Intervention Name(s)
Tenofovir Disoproxil Fumarate
Other Intervention Name(s)
TDF
Intervention Description
Tenofovir Disoproxil Fumarate was used for the experimental group of pregnancy women in the 32 weeks during pregnancy
Primary Outcome Measure Information:
Title
The incidence rate of hepatitis flare after drug withdrawal in maternal postpartum
Description
ALT > 3 times the upper limit of normal
Time Frame
after delivery 24weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA > 106 copies/ml
healthy Pregnant women with HBsAg(-), HBeAg(-)
Exclusion Criteria:
Active consumption of alcohol and/or drugs
Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus, HIV, etc.
History of autoimmune hepatitis
Psychiatric disease
Evidence of neoplastic diseases of the liver
without gestational hypertension, premature rupture of membranes, antepartum haemorrhage diseases or amniotic fluid piercing history during pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao Xie
Phone
8610-84322489
Email
xieyao00120184@sina.com
Facility Information:
Facility Name
Beijing Ditan hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao Xie, doctor
Phone
8613501093293
Email
xieyao00120184@sina.com
First Name & Middle Initial & Last Name & Degree
Yao Xie, doctor
12. IPD Sharing Statement
Citations:
PubMed Identifier
36109430
Citation
Li M, Sun F, Bi X, Lin Y, Yang L, Jiang T, Deng W, Lu Y, Zhang L, Yi W, Xie Y. Effects of antiviral therapy and drug withdrawal on postpartum hepatitis in pregnant women with chronic HBV infection. Hepatol Int. 2023 Feb;17(1):42-51. doi: 10.1007/s12072-022-10412-w. Epub 2022 Sep 15.
Results Reference
derived
PubMed Identifier
35677040
Citation
Wang F, Xie S, Ran C, Hao H, Jiang T, Deng W, Bi X, Lin Y, Yang L, Sun F, Zeng Z, Xie Y, Li M, Yi W. Effect of Antiviral Therapy During Pregnancy on Natural Killer Cells in Pregnant Women With Chronic HBV Infection. Front Immunol. 2022 May 23;13:893628. doi: 10.3389/fimmu.2022.893628. eCollection 2022.
Results Reference
derived
Learn more about this trial
The Incidence of Postpartum Hepatitis in Pregnant Women With Chronic Hepatitis B Virus Infection
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