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Switching From Tenofovir Disoproxi Fumarate to Tenofovir Alafenamide in Chronic Hepatitis B Patients With Antiviral Resistance

NCT03566030 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2018-06-21

No results posted yet for this study

Summary

* To evaluate the efficacy of switching to tenofovir alafenamide (TAF) 25 mg QD versus continued tenofovir disoproxil fumarate (TDF) 300 mg QD in CHB patients with antiviral resistance, as determined by the proportion of virologically suppressed patients at week 48
* To evaluate the safety and tolerability of switching to TAF 25 mg QD versus continuing TDF 300 mg QD in antiviral-resistant subjects with chronic HBV at week 48

Conditions

Interventions

DRUG

Tenofovir disoproxil fumarate 300mg

Administered Tenofovir disoproxil fumarate 300 mg QD

DRUG

Tenofovir Alafenamide 25 mg

Administered Tenofovir Alafenamide 25 mg QD

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-08-31
Completion
2020-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03566030 on ClinicalTrials.gov