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Nucleoside Analog Reverse Transcriptase Inhibitor

TAF for Chronic Hepatitis B

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 weeks for reporting.

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 • NCT01940341

19%

Headache

14%

Nasopharyngitis

13%

Upper respiratory tract infection

11%

Arthralgia

Cough

Back pain

Diarrhoea

Fatigue

Influenza

Nausea

Abdominal pain

Pain in extremity

Dyspepsia

Pharyngitis

Urinary tract infection

Dizziness

Hypertension

Hepatocellular carcinoma

Pancreatic carcinoma

Ureterolithiasis

Gastrooesophageal reflux disease

Calculus ureteric

100%

80%

60%

40%

20%

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