Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

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追踪信息

首次提交日期 ^ICMJE

September 20, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

December 29, 2010

预计主要完成日期

December 31, 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Child HBsAg 6 mo[ Time Frame: 6 months after delivery ]

Serum status of HBsAg of the infants at 6 months old

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Child HBsAg 12 mo[ Time Frame: 12 months after delivery ]
Serum status of HBsAg of the infants at 12 months old
Maternal ALT elevation[ Time Frame: 6 months after delivery ]
Rate of postpartum maternal ALT elevation above 2X upper limit of normal within 6 months after delivery
Maternal HBeAg-seroconverion[ Time Frame: 12 months after delivery ]
HBeAg-seroconversion rate within 12 months after delivery
Maternal renal[ Time Frame: 6 and 12 months post delivery ]
Maternal serum creatinine (mg/dL) at 6 and 12 months post delivery
Materna bone marker[ Time Frame: 6 and 12 months post delivery ]
Maternal bone alkaline phosphatase (ug/L) at 6 and 12 months post delivery
Children's growth[ Time Frame: 6 and 12 months after birth ]
Children's growth: height (cm) in Z score at 6 and 12 months after birth
Children's growth[ Time Frame: 6 and 12 months after birth ]
Children's growth: weight (kg) in Z score at 6 and 12 months after birth

描述性信息

简略标题 ^ICMJE

Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

正式标题 ^ICMJE

Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

简要概况

To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.

详细说明

This is a multi-centered study conducted in 12-16 collaborative hospitals in Taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. The study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (TDF) 2011-2018, June, and receive tenofovir alafenamide (TAF) 2018-2021. Control group did not receive antiviral treatment. Both group receive mother and infant follow-up up to 12 months after delivery.

研究类型 ^ICMJE

Interventional

研究阶段

Phase 4

研究设计 ^ICMJE

分配: Non-Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Prevention

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Tenofovir Alafenamide
Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.

研究工具

Experimental: treatment group
Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.
No Intervention: control group
control group receive no drug, only follow-up

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

360

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 31, 2021

预计主要完成日期

December 31, 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion criteria: - Women aged 20-45 years in 28 to 32 weeks of pregnancy - Positive HBsAg and HBeAg - Serum viral load above 6 log10 IU/mL Exclusion criteria: - Major systemic disease of the mother or fetus - Positive anti-HIV or anti-HCV - Under treatment of antiviral therapy - Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus - Pregnant woman whose amniocentesis reveals any genetic abnormality

性别

参与研究的性别:

Female

年龄

最小年龄：20 Years ，最大年龄：40 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

Taiwan

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

National Taiwan University Hospital

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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