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Nucleoside Reverse Transcriptase Inhibitor

Antiviral Therapy for Hepatitis B Transmission Prevention (REVERT-B Trial)

Phase 3

Recruiting

Led By Jodie Dionne, MD, MSPH

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥16 years

Active hepatitis B with risk of vertical transmission (HBsAg+ AND HBeAg+ or HBV DNA >1000 IU/ML)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-9 months of age

Awards & highlights

REVERT-B Trial Summary

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

Who is the study for?

This trial is for pregnant women over 16 years old in Africa, between 14-32 weeks of pregnancy, who have active hepatitis B with a high risk of passing it to their baby. They must plan to deliver at the study facility and be able to consent. Women can't join if they are HIV positive, have very high liver enzymes or serum creatinine levels, are already on tenofovir medication, or have known allergies to the study drugs.Check my eligibility

What is being tested?

The REVERT-B study is testing whether antiviral medications Tenofovir Disoproxil Fumarate and Lamivudine Oral Solution can prevent mothers from passing hepatitis B to their newborns during delivery. The effectiveness, safety, how well people tolerate the meds, and adherence will be monitored.See study design

What are the potential side effects?

Possible side effects include digestive issues like nausea or vomiting; fatigue; headache; dizziness; skin rash; and rarely kidney problems or bone pain. Side effects vary by individual.

REVERT-B Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 16 years old or older.

Select...

I have active hepatitis B with a high risk of passing it to others.

REVERT-B Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-9 months of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-9 months of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-9 months of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Vertical Transmission of hepatitis B Infection

Virologic Suppression

Secondary outcome measures

Composite Adverse Birth Outcomes

Hepatitis B Flare

In utero HBV infection

+5 more

Side effects data

From 2019 Phase 4 trial • 75 Patients • NCT03258710

25%

Nasopharyngitis

23%

Beta 2 microglobulin urine increased

Cough

Headache

Dental caries

Back pain

Osteoarthritis

Appendicitis

100%

80%

60%

40%

20%

Study treatment Arm

Tenofovir Disoproxil Fumarate

REVERT-B Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pregnant Women - TenofovirExperimental Treatment1 Intervention

Women will be randomized to early initiation (enrollment at 14-28 weeks pregnant) vs standard initiation (at 28 weeks pregnant) of tenofovir disoproxil fumarate (TDF) 300 mg daily oral medication until delivery.

Group II: Newborn Infants - LamivudinePlacebo Group1 Intervention

Infants exposed to HBV at birth will be randomized to receive oral lamivudine post-exposure prophylaxis or matching placebo. Medication will be administered twice daily for 6 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tenofovir Disoproxil Fumarate

2005

Completed Phase 4

~2080

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,593 Previous Clinical Trials

2,282,232 Total Patients Enrolled

4 Trials studying Hepatitis B

6,520 Patients Enrolled for Hepatitis B

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,976 Previous Clinical Trials

2,680,216 Total Patients Enrolled

4 Trials studying Hepatitis B

1,277 Patients Enrolled for Hepatitis B

Jodie Dionne, MD, MSPHPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Lamivudine Oral Solution (Nucleoside Reverse Transcriptase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04704024 — Phase 3

Hepatitis B Research Study Groups: Pregnant Women - Tenofovir, Newborn Infants - Lamivudine

Hepatitis B Clinical Trial 2023: Lamivudine Oral Solution Highlights & Side Effects. Trial Name: NCT04704024 — Phase 3

Lamivudine Oral Solution (Nucleoside Reverse Transcriptase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04704024 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being recruited for this research study?

"The age requirements for this study are that patients must be 16 years or older, and younger than 50."

Answered by AI

Has the FDA cleared Tenofovir Disoproxil Fumarate for public use?

"Tenofovir Disoproxil Fumarate's safety is rated highly by our team because it has gone through multiple stages of clinical trials, meaning that there is both efficacy and safety data supporting its use."

Answered by AI

What does Tenofovir Disoproxil Fumarate typically help patients with?

"The medical intervention of Tenofovir Disoproxil Fumarate can be used to treat human immunodeficiency virus type 1 (hiv-1) infection, hepatitis b, chronic and other therapeutic procedures."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Vertical Transmission of Hepatitis B in Africa

Jodie A. Dionne, MD 2021. "Reducing Vertical Transmission of Hepatitis B in Africa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04704024.

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