Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B (TAF-PPT)

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ClinicalTrials.gov Identifier: NCT04850950

Recruitment Status : Not yet recruiting

First Posted : April 20, 2021

Last Update Posted : April 23, 2021

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Sponsor:

Collaborators:

National Natural Science Foundation of China

Henan Provincial People's Hospital

The Sixth People's Hospital of Zhengzhou

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Second Affiliated Hospital of Xi'an Jiaotong University

Shandong Provincial Hospital

Luoyang Central Hospital

First Affiliated Hospital of Nanyang Medical College

Sixth People's Hospital of Kaifeng

Luohe Central Hospital

Xinyang Central Hospital

Yan'an University Affiliated Hospital

Nanyang Central Hospital

Fifth People's Hospital of Anyang

Information provided by (Responsible Party):

Qing-Lei Zeng, The First Affiliated Hospital of Zhengzhou University

Study Description

Brief Summary:

To investigate the safety and efficacy of tenofovir alafenamide (orally 25 mg per day) treated in inactive chronic hepatitis B virus (HBV)-infected pregnant women with high viral load from the late pregnancy until the delivery date or postpartum 1 month.

Condition or disease	Intervention/treatment	Phase
Chronic Hepatitis B Mother-to-Child Transmission Safety Efficacy Hepatitis B Virus Tenofovir Alafenamide Fumarate	Drug: Tenofovir Alafenamide fumarate 25mg Oral Tablet	Phase 4

Detailed Description:

The investigators intend to include 240 inactive chronic hepatitis B virus (HBV)-infected pregnant women who have an HBV DNA level higher than 200,000 IU per milliliter. Participants will be randomly assigned, in a 1:1 ratio, to receive tenofovir alafenamide (orally 25 mg per day) from the late pregnancy until the delivery date or postpartum 1 month. All the infants will receive standard immunoprophylaxis (100 IU of hepatitis B immunoglobulin and 10 μg of hepatitis B vaccine within 12 hours of birth; the second injection of 10 μg of HBV vaccine will inject at 1 month; and the third dose of 10 μg of HBV vaccine will give at 6 months). The pregnant women and their infants will be followed until postpartum month 7. The primary outcomes are the birth defects and rates of perinatal transmission of HBV. During the prenatal period or the postnatal period up to 7 months of age, cases of a structural defect in newborns or infants were reported as birth defects. The rate of perinatal transmission was defined as the proportion of infants who are positive for hepatitis B surface antigen at 7 months of age. The secondary safety outcomes are the occurrence of maternal or infant adverse events during the study period. Maternal safety evaluations mainly include any adverse events and complications, hepatitis B virologic breakthrough, alanine aminotransferase flare, and so on. Infant' safety profiles mainly included Apgar scores at 1 minute, any abnormal conditions during the study period, and anthropometric indexes at birth and 7 months of age. The secondary efficacy outcomes are the percentages of mothers with an HBV DNA level of less than 200,000 IU per milliliter just before or at delivery, and the hepatitis B e antigen and surface antigen loss or seroconversion in mothers at postpartum month 7.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	240 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Safety and Efficacy of Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B (TAF-PPT): A Multicentre, Prospective, Open-label, Randomized Controlled Trial
Estimated Study Start Date :	April 26, 2021
Estimated Primary Completion Date :	December 31, 2022
Estimated Study Completion Date :	December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Formic acid Tenofovir Tenofovir Disoproxil Tenofovir Disoproxil Fumarate Tenofovir Alafenamide Tenofovir Alafenamide fumarate

Genetic and Rare Diseases Information Center resources: Herpes Simiae (B Virus)

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1 Tenofovir alafenamide fumarate discontinued at delivery date.	Drug: Tenofovir Alafenamide fumarate 25mg Oral Tablet Tenofovir alafenamide fumarate initiated from the late pregnancy to the delivery date or postpartum month 1. Other Name: VEMLIDY®
Experimental: Arm 2 Tenofovir alafenamide fumarate discontinued at postpartum month 1.	Drug: Tenofovir Alafenamide fumarate 25mg Oral Tablet Tenofovir alafenamide fumarate initiated from the late pregnancy to the delivery date or postpartum month 1. Other Name: VEMLIDY®

Outcome Measures

Primary Outcome Measures :

Birth defects. [ Time Frame: From prenatal tenofovir alafenamide exposure to the birth and postnatal period up to 7 months of age. ]
Structural defect in newborns or infants were reported as birth defects. The monitoring of birth defects was conducted by a clinical examination during each visit, and further clinical imaging or other tests were performed if indicated. The birth defect rate represented the proportion of infants with a defect among all live births.
The rate of perinatal transmission of hepatitis B virus. [ Time Frame: At 7 months of age. ]
The rate of perinatal transmission was defined as the proportion of infants who are positive for hepatitis B surface antigen at 7 months of age.

Secondary Outcome Measures :

Adverse events. [ Time Frame: From prenatal tenofovir alafenamide exposure to the delivery (birth) and postnatal period up to 7 months (of age). ]
The occurrence of any maternal or infant adverse events.
Alanine aminotransferase flare. [ Time Frame: At postpartum month 7. ]
Alanine aminotransferase flare was defined as a level greater than 5 or 10 times the upper limit of normal, which was set as 40 U/L according to the Asian-Pacific chronic hepatitis B guideline.
Infants' growth. [ Time Frame: At birth and 7 months of age. ]
Infant growth was measured by the WHO z scores for age for weight, height, and head circumference.
HBV DNA level. [ Time Frame: Immediately before or at delivery. ]
Percentage of HBV DNA level of less than 200,000 IU per milliliter for mothers.
Hepatitis B e antigen status. [ Time Frame: At postpartum month 7. ]
Percentage of hepatitis B e antigen loss or seroconversion for mothers.
Hepatitis B surface antigen status. [ Time Frame: At postpartum month 7. ]
Percentage of hepatitis B surface antigen loss or seroconversion for mothers.

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Gender Eligibility Description:	Pregnant women.
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Gestational age of more than 30 weeks;
Had chronic hepatitis B virus (HBV) infection;
HBV DNA > 200,000 IU/ml;
Consecutively normal levels of alanine aminotransferase (< 40 U/L) and total bilirubin (< 17.1 μmol/L);
Willing and able to provide written informed consent and adhere to the trial protocol.

Exclusion Criteria:

Previous treatment to reduce alanine aminotransferase and total bilirubin levels;
Previous antiviral treatment for HBV infection (except when antiviral agents were administered for the prevention of perinatal transmission during a previous pregnancy and discontinued more than 6 months before the current pregnancy);
Coinfection with hepatitis C, D, E, or human immunodeficiency virus;
Previous or current evidence of hepatocellular carcinoma, cirrhosis, systemic or other organ disorders;
A hemoglobin level of less than 80 g/L;
A neutrophil count of less than 1.0 × 10^9/L;
An albumin level of less than 30 g/L;
Clinical signs of threatened miscarriage;
Evidence of fetal deformity by ultrasound examination and other tests;
A history of abortion, pregnancy loss, or congenital malformation in a previous pregnancy;
A history of genetic disease(s), including the family member(s);
Concurrent treatment with other drugs, including but not limited to nephrotoxic drugs, immune modulators, cytotoxic drugs, nonsteroidal antiinflammatory drugs, or steroids.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04850950

Contacts

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Contact: Qing-Lei Zeng, M.D.	86 15838120512	zengqinglei2009@163.com
Contact: Zu-Jiang Yu, M.D.	86 186 0371 0022	johnyuem@zzu.edu.cn

Sponsors and Collaborators

The First Affiliated Hospital of Zhengzhou University