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Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)

NCT03471624•Stanford University

View on ClinicalTrials.gov

Summary

Primary Objective: To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV (hepatitis B virus) treatment

Detailed Description

Secondary Objective(s): 1. Describe persistence of ALT (alanine aminotransferase) normalization and/or improvement of ALT levels with TAF as with previous anti-HBV treatment 2. To describe trends in serum creatinine and calculated creatinine clearance as available by local labs. 3. To describe trends in bone mass from baseline to 24 months after switch. https://med.stanford.edu/nguyenlab/clinical-trials.html

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, age ≥18 years
•2. Chronic hepatitis B diagnosis confirmed by positive HBsAg or HBV DNA or HBeAg or documented history of chronic hepatitis B in physician note
•3. Currently maintained on antiviral therapy for at least 48 weeks with any Hepatitis B virus(HBV) DNA value at Screening/Baseline and planned to be switched to TAF by their physician
•4. Routinely monitored for serum HBV DNA Polymerase chain reaction(PCR), liver chemistry including Aspartate aminotransferase (AST )/alanine transaminase(ALT)/total bilirubin, renal chemistry including Blood urea nitrogen(BUN)/Creatinine/Carbon dioxide (CO2) by their physicians every 3-6 months and a bone density scan at least every 2 years as per routine clinical care (one at baseline and one 2 years after switch).
•5. Estimated creatinine clearance \> 15 ml/min (using the Cockcroft-Gault method) at Screening/Baseline Visit. (Note: multiply estimated rate by 0.85 for women).
•6. Willing and able to provide informed consent
•7. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments

Exclusion Criteria

•1. Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
•2. Previous recipient of a liver transplant
•3. Co-infection with human immunodeficiency virus (HIV) or hepatitis C (HCV) or hepatitis D (HDV)
•4. Severe or uncontrolled comorbidities
•5. Current or known hepatic decompensation (≤2 years) (e.g ascites, encephalopathy, or variceal hemorrhage) with a Child-Pugh score of B or C
•6. Malignancy including liver cancer within 5 years except cancers curable by surgical resection (e.g. basal cell skin cancer and squamous cell cancer)
•7. On any of the disallowed concomitant medications listed in the prior and concomitant medications list (pg. 11). Subjects on prohibited medications who are otherwise eligible will need a wash out period of at least 30 days prior to the Screening/Baseline visit.
•8. Males and females of reproductive potential who are unwilling to use "effective" protocol-specified method(s) of contraception during the study.
•9. Current substance or alcohol abuse judged by the investigator to potentially interfere with subject compliance.
•10. Any other clinical conditions that, in the opinion of the Investigator, would make the subject unsuitable or unable to comply with any of the study procedures

Locations (12)

Stanford University Medical Center

Palo Alto, California, United States

San Jose Gastroenterology

San Jose, California, United States

Kyushu University Hospital

Fukuoka, Japan

Nagoya City University

Nagoya, Japan

Osaka City University

Osaka, Japan

Saga University Hospital

Saga, Japan

Hanyang University Seoul Hospital

Seoul, South Korea

Nowon Eulji Medical Center, Eulji University College of Medicine,

Seoul, South Korea

Sanggye Paik Hospital, Inje University College of Medicine

Seoul, South Korea

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Key Dates

Start Date

May 1, 2018

Primary Completion Date

April 19, 2022

Completion Date

April 19, 2022

Last Updated

November 18, 2023

Enrollment

270

ACTUAL participants

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir Alafenamide

DRUG

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

NCT04166266

Hepatitis D, ChronicHepatitis B, Chronic

View study

RECRUITING

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

NCT06550622

Hepatitis B, Chronic

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RECRUITINGEARLY_PHASE1

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)

Inclusion Criteria

Exclusion Criteria

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels