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Nucleoside Analog Reverse Transcriptase Inhibitor
Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen
Phase 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 weeks
Awards & highlights
Pivotal Trial
Summary
This trial compares two medications, TAF and TDF, to see which is better for treating adults with a specific type of chronic hepatitis B. These drugs work by reducing the virus's ability to replicate in the body. TAF is a newer version of tenofovir developed to treat chronic hepatitis B with improved safety profiles compared to TDF.
Eligible Conditions
- Chronic Hepatitis B
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Other study objectives
Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48
Side effects data
From 2022 Phase 3 trial • 426 Patients • NCT0194034119%
Headache
14%
Nasopharyngitis
13%
Upper respiratory tract infection
11%
Arthralgia
9%
Cough
7%
Back pain
6%
Diarrhoea
6%
Fatigue
6%
Influenza
6%
Nausea
5%
Abdominal pain
5%
Pain in extremity
4%
Dyspepsia
4%
Pharyngitis
3%
Urinary tract infection
3%
Dizziness
3%
Hypertension
1%
Hepatocellular carcinoma
1%
Pancreatic carcinoma
1%
Ureterolithiasis
1%
Gastrooesophageal reflux disease
1%
Calculus ureteric
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-blind Phase: TAF 25 mg
Double-blind Phase: TDF 300 mg
Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg
Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: TAF 25 mgExperimental Treatment2 Interventions
TAF + TDF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
Group II: Open-label TAFExperimental Treatment1 Intervention
All participants who complete the double-blind period (96 weeks or 144 weeks) will be eligible to receive open-label TAF until Week 384 of the study.
After the end of study treatment, participants can either switch to commercially available anti-HBV treatments in their country or will be followed every 4 weeks, for up to 24 weeks off treatment (treatment-free follow-up (TFFU)) for safety assessment.
Group III: TDF 300 mgActive Control2 Interventions
TDF + TAF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAF
2015
Completed Phase 3
~2740
TDF Placebo
2015
Completed Phase 3
~2410
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,135 Previous Clinical Trials
867,161 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
360 Previous Clinical Trials
191,612 Total Patients Enrolled