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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

Tracking Information
First Submitted Date August 18, 2019
First Posted Date August 22, 2019
Last Update Posted Date August 22, 2019
Estimated Study Start Date August 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus
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)
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 64 Weeks
Biospecimen Not Provided
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.
Condition
  • Hepatitis B Virus
  • Mother to Child Transmission
Intervention 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.
Study Groups/Cohorts TAF antiviral therapy group
Intervention: Drug: Tenofovir Alafenamide Fumarate tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 20, 2019)
330
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Guorong Han 13851623507 hgr518@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04065230
Other Study ID Numbers H201908
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Guo-rong Han, Southeast University, China
Study Sponsor Southeast University, China
Collaborators Not Provided
Investigators Not Provided
PRS Account Southeast University, China
Verification Date August 2019