NCT03214302

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
560

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

July 4, 2017

Last Update Submit

July 11, 2017

Conditions

Chronic Hepatitis B

Keywords

antiviral treatmenthepatitis B viruspregnant womanPostpartum hepatitis

Outcome Measures

Primary Outcomes (1)

  • The incidence rate of hepatitis flare after drug withdrawal in maternal postpartum

    ALT \> 3 times the upper limit of normal

    after delivery 24weeks

Study Arms (2)

control group

NO INTERVENTION

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(-)

experimental group

EXPERIMENTAL

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.

Drug: Tenofovir Disoproxil Fumarate

Interventions

Tenofovir Disoproxil FumarateDRUG

Tenofovir Disoproxil Fumarate was used for the experimental group of pregnancy women in the 32 weeks during pregnancy

Also known as: TDF
experimental group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA \> 106 copies/ml
  • healthy Pregnant women with HBsAg(-), HBeAg(-)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Ditan hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 36109430DERIVED

  • 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.

    PMID: 35677040DERIVED

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Yao Xie

CONTACT

8610-84322489xieyao00120184@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of liver diseases center

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 11, 2017

Study Start

January 1, 2017

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

CN(1)