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Nucleoside Analog Reverse Transcriptase Inhibitor

Tenofovir Alafenamide for 24 months for Chronic Hepatitis B

Phase 4
Waitlist Available
Led By Mindie H Nguyen, MD,MAS
Research Sponsored by Stanford University
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 baseline, 6, 12, 18, 24 months
Awards & highlights

Study Summary

This trial is looking at the difference in how well two different drugs work to suppress the hepatitis B virus.

Eligible Conditions
  • Chronic Hepatitis B

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6, 12, 18, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6, 12, 18, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With HBV DNA <20 IU Per mL
Secondary outcome measures
Calculated eGFR
Number of Participants With Normal Alanine Aminotransferase (ALT).
The Mean Bone Mass Density (T-score) Change

Side effects data

From 2022 Phase 4 trial • 270 Patients • NCT03471624
1%
Hepatocellular carcinoma
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tenofovir Alafenamide for 24 Months

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tenofovir Alafenamide for 24 monthsExperimental Treatment1 Intervention
Participants on any antiviral treatment for chronic HBV who plan to be switched by their physician to be treated with TAF 25 mg for 24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir Alafenamide
2017
Completed Phase 4
~1580

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,340,922 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,083 Previous Clinical Trials
843,229 Total Patients Enrolled
Mindie H Nguyen, MD,MASPrincipal InvestigatorStanford University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
Mindie H. Nguyen 2018. "Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03471624.
~39 spots leftby Apr 2025
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