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Study of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus

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ClinicalTrials.gov Identifier: NCT04065230
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Guo-rong Han, Southeast University, China

Brief Summary:
This study is a single-group, multi-center and prospective clinical study designed to assess the efficacy and safety of TAF in blocking mother-to-child transmission of hepatitis B virus.Pregnant women whose HBsAg and HBeAg are positive are included in the study.Eligible hepatitis B pregnant women are given TAF antiviral therapy at 24-28 weeks of gestation to block mother-to-child transmission and followed up during pregnancy and after delivery.The study will be initiated with approval by the central ethics committee.Subjects will start screening after signing the informed consent form. Those who meet the criteria will start taking TAF (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.At that time, chronic hepatitis B carrier will stop taking antiviral therapy, and patients with chronic hepatitis B decide whether to continue the therapy according to the patient's condition.The babies born are immunized according to the national standard immunization program,, that is, 100 IU of hepatitis B immunoglobulin (HBIG) and 10 μg/0.5 ml of hepatitis B vaccine are given within 12 hours after birth. And the same dose of hepatitis B vaccine is given at 1 month and 6 months of age.

Condition or disease Intervention/treatment
Hepatitis B Virus Mother to Child Transmission Drug: Tenofovir Alafenamide Fumarate tablets

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 64 Weeks
Official Title: A Prospective,Multi-center,Cohort Trial: the Efficacy and Safety of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus(HBV)
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021


Group/Cohort Intervention/treatment
TAF antiviral therapy group Drug: Tenofovir Alafenamide Fumarate tablets
Eligible hepatitis B pregnant women are given TAF antiviral therapy (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.




Primary Outcome Measures :
  1. MTCT rates in the TAF treated mothers [ Time Frame: 28 weeks post-partum ]
    detectable levels of HBV DNA or HBsAg in the peripheral serum samples of infants at age 28 weeks



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women in the Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing) whose HBsAg and HBeAg are positive are enrolled in the study. TAF is used as antiviral therapy during 24-28 week of gestation.The safety and efficacy of TAF are evaluated.
Criteria

Inclusion Criteria:

  • maternal age: 20 to 35 years
  • 20-24 week of gestation
  • HBsAg-positive more than 6 months and HBeAg-positive
  • HBV DNA> 1000,000 IU/ml
  • both husband and wife voluntarily sign informed consent
  • with good compliance and comply with follow-up programs

Exclusion Criteria:

  • mother with co-infection of hepatitis C virus,human immunodeficiency virus
  • evidence of decompensated liver disease
  • combined with important organ lesions which will affect patient compliance and follow-up plans, pregnant women who are expected to be difficult to complete the study
  • have a history of spontaneous abortion, or have a birth defect or congenital malformation in the last pregnancy
  • mother treated with antiviral therapy within 6 months prior to enrollment(except those treated with antiviral therapy in the last pregnancy to prevent mother-to-child transmission)
  • have a history of kidney injury, creatinine clearance <50ml/min, urine protein positive (>300mg/L)
  • combined with other chronic diseases and need to take immunomodulators, cytotoxic drugs or hormonal drugs during pregnancy
  • the infants' biologic father is a chronic HBV infected person
  • symptoms of threatened abortion during early pregnancy
  • evidence of hepatic cell carcinoma
  • alanine aminotransferase (ALT) > 10 x upper limit of normal(ULN ), or total bilirubin (TBIL) > 3 x ULN or glomerular filtration rate (GFR) < 90 mL (min*1.73 m2), or serum Albumin (ALB) < 25 g/L before enrollment
  • fetal malformations detected by B-ultrasound
  • participants in other research

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): NCT04065230


Contacts
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Contact: Guorong Han 13851623507 hgr518@163.com

Locations
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China, Jiangsu
The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing) Recruiting
Nanjing, Jiangsu, China, 210003
Contact: Guorong Han    13851623507    hgr518@163.com   
Sponsors and Collaborators
Southeast University, China

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Responsible Party: Guo-rong Han, Director of Obstetrics and Gynecology, Southeast University, China
ClinicalTrials.gov Identifier: NCT04065230     History of Changes
Other Study ID Numbers: H201908
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Tenofovir
Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents