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

Chronic Hepatitis B Clinical Trial

— SWITAF  

Official title:

Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching From TDF to TAF vs. Maintaining TDF

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03356834
• Other study ID #: HumanityHGLC
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2017
• Est. completion date: October 2024

Study information

• Verified date: December 2022
• Source: Humanity and Health Research Centre
• Contact: Cheng Wang, M.D. PhD
• Phone: 21539831
• Email: wangcheng[@]hnhmgl.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Tenofovir disoproxil fumarate(TDF) have been associated with renal toxicity and reduced bone mineral density. Tenofovir alafenamide(TAF) is a novel tenofovir prodrug that reduces tenofovir plasma concentrations by 90%, thereby decreasing off-target side-effects. The investigators aimed to assess whether efficacy, safety, and tolerability were non-inferior in participants switched to TAF versus in those remaining on TDF. This is a prospective clinical study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Chronic hepatitis B,

2. Antiviral experienced,

3. Currently on long term TDF anti-HBV treatment,

4. HBV DNA < 6 log IU/ml (LLOD)

5. Able to sign the consent form of anticipating in the study

Exclusion Criteria:

1. Co-infected with HCV, HIV or other viral hepatitis,

2. Diagnosis of HCC

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Tenofovir alafenamide(TAF)
25 mg tablet administered orally once daily
• Tenofovir disoproxil fumarate(TDF)
300 mg tablet administered orally once daily

Locations

Country	Name	City	State
Hong Kong	Humanity and Health GI and Liver Centre	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Humanity and Health Research Centre

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antiviral response of TAF	Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients	60 months
Secondary	Improvement of renal function and bone mineral density in CHB patients switching to TAF	Change of renal function and bone mineral density from baseline in CHB patients of TAF a group compared with TDF group	60 months