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Maternal Therapy With TAF Versus TDF to Prevent Vertical Transmission of Hepatitis B

NCT04211805 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2020-12-29

No results posted yet for this study

Summary

Immunoprophylaxis failure of hepatitis B (HBV) remains a concern and has been reported in approximately 10-30% of infants born to highly viremic mothers with HBeAg-positive. Maternal HBV DNA \>6log10 copies/mL (or 200,000 IU/mL) is the major independent risk for mother-to-child transmission (MTCT). Two recent random controlled trial (RCT) studies have shown that the use of Tenofovir Disoproxil Fumarate (TDF) in highly viremic HBsAg positive mothers may safely reduce the rate of MTCT when compared between groups of TDF treated and untreated patients. Tenofovir Alafenamide (TAF) is the successor to TDF, and both drugs have a similar mechanism of action to reduce HBV DNA levels and normalize serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse effects. TAF however, has a better safety profile with less adverse effects to bone mineral density and renal function. The present prospective, double-arm study is to evaluate the non-inferiority in the efficacy and safety of TAF therapy versus TDF therapy in highly viremic mothers and their infants for the prevention of MTCT in the real world setting.

Conditions

  • Hepatitis B, Chronic
  • Pregnancy Related

Interventions

DRUG

Tenofovir Alafenamide 25 MG for arm (A)

Tenofovir Alafenamide (TAF) will be provided, 25 mg Per Oral daily.

DRUG

Tenofovir Disoproxil Fumarate 300mg for arm (B)

Tenofovir Disoproxil Fumarate (TDF) will be provided, 300 mg Per Oral daily.

Sponsors & Collaborators

  • New Discovery LLC

    lead INDUSTRY

Principal Investigators

  • Calvin Pan, MD · Beijing Ditan Hospital, Capital Medical University; NYU Langone Health, NY, USA

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-27
Primary Completion
2021-09-30
Completion
2021-09-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04211805 on ClinicalTrials.gov