NCT02510963

Brief Summary

To determine the optimal time for the Tenofovir treatment of anti-Hepatitis B Virus (HBV) during the pregnancy among women with chronic HBV infection and high HBV DNA load. This is a randomized, open-label, three-arms, parallel-controlled clinical trial. Pregnant women with high HBV load and normal liver function will be treated with tenofovir during the middle or late stage of pregnancy, started from 24th gestational week, 28th gestational week and 32th gestational week through 1 month postpartum, respectively. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants will be compared across the three groups.

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

1.6 years

First QC Date

July 22, 2015

Last Update Submit

August 9, 2016

Conditions

Hepatitis B, Chronic

Keywords

Vertical infection transmissionTenofovir

Outcome Measures

Primary Outcomes (1)

  • HBV DNA load in serum

    the difference in the percentage of mothers whose HBV DNA load in serum are less than 10\*2 IU/ml at delivery among the groups

    40 weeks, from randomization to delivery

Secondary Outcomes (3)

  • Intrauterine HBV infection rate of infants

    12 months, from delivery to one-year birth date

  • Change in HBV DNA load

    40 weeks, from randomization to delivery

  • Change in hepatitis B e antigen (HBeAg) titer

    40 weeks, from randomization to delivery

Study Arms (3)

Tenofovir 24 week

EXPERIMENTAL

Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 24 weeks of gestation to 1 month postpartum

Drug: Tenofovir Disoproxil Fumarate

Tenofovir 28 week

EXPERIMENTAL

Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 28 weeks of gestation to 1 month postpartum

Drug: Tenofovir Disoproxil Fumarate

Tenofovir 32 week

ACTIVE COMPARATOR

Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 32 weeks of gestation to 1 month postpartum

Drug: Tenofovir Disoproxil Fumarate

Interventions

Tenofovir Disoproxil FumarateDRUG

Use Tenofovir at 24week of gestation

Also known as: Tenofovir
Tenofovir 24 week

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women between 20 and 40 years old
  • Have had HBsAg positive in serum greater than 6 months
  • HBV DNA load\>10\*\*6 IU/ml
  • Gestation week\<24 weeks
  • Normal liver function
  • Able to comprehend and willing to sign the informed consent form

You may not qualify if:

  • Combined with following infections: hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV) and human immunodeficiency virus (HIV)
  • Got antiviral treatments before 24 weeks of Gestation
  • Got immunosuppressor treatment and/or steroids
  • Got diagnosis of cirrhosis,hepatocellular carcinoma or severe hepatitis B
  • Got serious obstetric complications
  • Got evidence of fetal deformity diagnosed by four-dimensional color Doppler ultrasound examination
  • Biological father of infant had HBV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710061, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-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

Study Officials

  • Tianyan Chen, MD,PHD

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinfeng Liu, MB

CONTACT

+86-13259927840prettycaofurong@163.com

Jing Wang, MD,PHD

CONTACT

+86-18092691661kidip@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 29, 2015

Study Start

November 1, 2015

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

CN(1)