- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04850950
Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B (TAF-PPT)
April 21, 2021 updated by: Qing-Lei Zeng, The First Affiliated Hospital of Zhengzhou University
Safety and Efficacy of Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B (TAF-PPT): A Multicentre, Prospective, Open-label, Randomized Controlled Trial
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
240
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qing-Lei Zeng, M.D.
- Phone Number: 86 15838120512
- Email: zengqinglei2009@163.com
Study Contact Backup
- Name: Zu-Jiang Yu, M.D.
- Phone Number: 86 186 0371 0022
- Email: johnyuem@zzu.edu.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm 1
Tenofovir alafenamide fumarate discontinued at delivery date.
|
Tenofovir alafenamide fumarate initiated from the late pregnancy to the delivery date or postpartum month 1.
Other Names:
|
EXPERIMENTAL: Arm 2
Tenofovir alafenamide fumarate discontinued at postpartum month 1.
|
Tenofovir alafenamide fumarate initiated from the late pregnancy to the delivery date or postpartum month 1.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From prenatal tenofovir alafenamide exposure to the birth and postnatal period up to 7 months of age.
|
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.
|
At 7 months of age.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From prenatal tenofovir alafenamide exposure to the delivery (birth) and postnatal period up to 7 months (of age).
|
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.
|
At postpartum month 7.
|
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.
|
At birth and 7 months of age.
|
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.
|
Immediately before or at delivery.
|
Hepatitis B e antigen status.
Time Frame: At postpartum month 7.
|
Percentage of hepatitis B e antigen loss or seroconversion for mothers.
|
At postpartum month 7.
|
Hepatitis B surface antigen status.
Time Frame: At postpartum month 7.
|
Percentage of hepatitis B surface antigen loss or seroconversion for mothers.
|
At postpartum month 7.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Qing-Lei Zeng, The First Affiliated hospital of Zhengzhou University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
April 26, 2021
Primary Completion (ANTICIPATED)
December 31, 2022
Study Completion (ANTICIPATED)
December 31, 2022
Study Registration Dates
First Submitted
April 9, 2021
First Submitted That Met QC Criteria
April 14, 2021
First Posted (ACTUAL)
April 20, 2021
Study Record Updates
Last Update Posted (ACTUAL)
April 23, 2021
Last Update Submitted That Met QC Criteria
April 21, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
Other Study ID Numbers
- 2021-KY-0144-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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