Tenofovir Disoproxil Fumarate for Hepatitis B

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hepatitis BTenofovir Disoproxil Fumarate - Drug
Eligibility
16 - 50
Female
What conditions do you have?
Select

Study Summary

This trial will test a new strategy to prevent hepatitis B transmission from women to newborns in Africa.

Eligible Conditions
  • Hepatitis B

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: 6-9 months of age

24 weeks after delivery
Hepatitis B Flare
Week 24
Infant Adherence to 3TC
6-9 months of age
Vertical Transmission of hepatitis B Infection
assessed at delivery
Preterm delivery
assessed at time of delivery
Retention in Prenatal Care
at birth
In utero HBV infection
at delivery
Incident HIV infection during pregnancy
Maternal Adherence to TDF
Virologic Suppression
Day 28
Composite Adverse Birth Outcomes

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Tenofovir Disoproxil Fumarate
25%Nasopharyngitis
23%Beta 2 microglobulin urine increased
5%Cough
5%Dental caries
5%Back pain
5%Headache
1%Appendicitis
1%Osteoarthritis
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT03258710) in the Tenofovir Disoproxil Fumarate ARM group. Side effects include: Nasopharyngitis with 25%, Beta 2 microglobulin urine increased with 23%, Cough with 5%, Dental caries with 5%, Back pain with 5%.

Trial Design

2 Treatment Groups

Pregnant Women - Tenofovir
1 of 2
Newborn Infants - Lamivudine
1 of 2

Experimental Treatment

Non-Treatment Group

450 Total Participants · 2 Treatment Groups

Primary Treatment: Tenofovir Disoproxil Fumarate · Has Placebo Group · Phase 3

Pregnant Women - Tenofovir
Drug
Experimental Group · 1 Intervention: Tenofovir Disoproxil Fumarate · Intervention Types: Drug
Newborn Infants - Lamivudine
Drug
PlaceboComparator Group · 1 Intervention: Lamivudine Oral Solution · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir disoproxil
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6-9 months of age

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,824 Previous Clinical Trials
2,249,007 Total Patients Enrolled
4 Trials studying Hepatitis B
1,277 Patients Enrolled for Hepatitis B
University of Alabama at BirminghamLead Sponsor
1,434 Previous Clinical Trials
2,228,772 Total Patients Enrolled
4 Trials studying Hepatitis B
6,520 Patients Enrolled for Hepatitis B
Jodie Dionne, MD, MSPHPrincipal InvestigatorUniversity of Alabama at Birmingham

Eligibility Criteria

Age 16 - 50 · Female Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are in the 14th to 32nd week of your pregnancy, as estimated by both a last menstrual period and ultrasound.
You have an active form of hepatitis B with the potential to be transmitted through childbirth.
You intend to receive post-treatment care and deliver at the research facility.
You are capable of granting knowledgeable approval.
You are an individual who visits a prenatal clinic.
You are at least 16 years of age.