Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF

NCT03356834 | Completed Phase 4 DMC

• 1 other identifier: HumanityHGLC
• Study Type: interventional
• Target: 575
• Locations: 1 country
• Sites: 1

Brief Summary

In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs), majority of these CHB patients experienced drug resistance and switched to Tenofovir disoproxil fumaratate(TDF). However, some of patients on long term TDF experienced impairment of renal function and bone mineral density. After Tenofovir alafenamide(TAF) was in clinical practice, these group of patients got an clinical option to switch from TDF to TAF. The investigators designed a prospective cohort study to evaluate the real life effectiveness and safety in participants with chronic HBV infection switch from TDF to TAF vs. maintaining on TDF.

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis B; Efficacy, safety, and tolerability; Tenofovir alafenamide

Outcome Measures

Primary Outcomes (1)

• Antiviral response of TAF

  Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients

  60 months

Secondary Outcomes (1)

• Improvement of renal function and bone mineral density in CHB patients switching to TAF

  60 months

Study Arms (2)

TDF switch to TAF

EXPERIMENTAL

Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Tenofovir Alafenamide(TAF) 25mg daily

Drug: Tenofovir alafenamide(TAF)

Maintaining on TDF

ACTIVE COMPARATOR

Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily

Drug: Tenofovir disoproxil fumarate(TDF)

Interventions

Tenofovir alafenamide(TAF) DRUG

25 mg tablet administered orally once daily

Also known as: VEMLIDY®

TDF switch to TAF

Tenofovir disoproxil fumarate(TDF) DRUG

300 mg tablet administered orally once daily

Also known as: VIREAD®

Maintaining on TDF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hepatitis B,
• Antiviral experienced,
• Currently on long term TDF anti-HBV treatment,
• HBV DNA \< 6 log IU/ml (LLOD)
• Able to sign the consent form of anticipating in the study

You may not qualify if:

• Co-infected with HCV, HIV or other viral hepatitis,
• Diagnosis of HCC

Sponsors & Collaborators

• Humanity and Health Research Centre: lead

Study Sites (1)

Humanity and Health GI and Liver Centre

Hong Kong, Hong Kong, 00852, Hong Kong

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

tenofovir alafenamide; Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Humanity & Healthy Medical Group President

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: November 29, 2017
• Study Start: December 1, 2017
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)