NCT05423834Active, not recruiting
Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir
Source: ClinicalTrials.gov · Last updated 8 Feb 2023
Brief summary (registry, in English)
Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection. TAF has been shown to be a potent inhibitor of HBV replication at a low dose, with high intracellular concentration and more than 90% lower systemic TFV concentration than tenofovir disoproxil fumarate (TDF). TAF has been approved in the clinical practice guidelines in the west. Since its availability in Asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials. The primary objective of this study is to compare the risk of chronic kidney disease (CKD) progression in chronic hepatitis B patients on TAF versus ETV in a territory-wide cohort in Hong Kong.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1800 (estimated)
- First submitted
- 13 Jun 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 21 Dec 2025
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Hepatitis B, Chronic kidney disease
- NCT number
- NCT05423834
What you commit to
- Study type: Observational
- Planned participants: 1800
- From 1 Sept 2022 to the primary completion date, 21 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous NA treatment prior to TAF or ETV
Other illness
- Positive antibody against hepatitis C, D, or human immunodeficiency virus (anti-HCV, anti-HDV, or anti-HIV)
- Evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease).
- Moribund state including advanced/pre-terminal liver cancer or other non-hepatic cancers
- Non-hepatic cancer undergoing chemotherapy within last 6 months
Who the study is looking for
- Positive hepatitis B surface antigen (HBsAg) or documented history of CHB for 6 months or more; AND
- On TAF 25 mg daily as antiviral treatment for CHB (cases); OR
- On ETV 0.5 to 1.0 mg daily as antiviral treatment for CHB (controls)
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin | Hong Kong | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.