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The Renal Safety of Tenofovir Alafenamide in HBV-related Acute-on-chronic Liver Failure: Real-World Study

Sponsor
Xiangya Hospital of Central South University (Other)
Overall Status
Completed
CT.gov ID
NCT05453448
Collaborator
(none)
272
Enrollment
1
Location
2
Arms
29
Actual Duration (Days)
285.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Tenofovir alafenamide (TAF) and entecavir (ETV) are the preferred agents in patients with predisposing factors for nephrotoxicity, but few studies to date have directly compared the renal safety of the two antiviral drugs in patients with acute-on-chronic liver failure (ACLF). Hence, the investigators compared the risk of kidney function decline among patients with HBV related acute-on-chronic liver failure (HBV-ACLF) treated with ETV or TAF.From April 2020 to June 2021, a total of 272 HBV-related ACLF hospitalized patients in the Xiangya Hospital of Central South University were enrolled in this prospective study. Chronic hepatitis B was diagnosed by hepatitis B surface antigen and/or hepatitis B virus deoxyribonucleic acid (HBV-DNA) positivity for ≥6 months. ACLF was diagnosed based on the criteria proposed by the APASL Working Party. All patients received antiviral therapy with TAF (25 mg QD, n=100) or ETV (0.5mg QD, n=172), and comprehensive medical treatments. Clinical and laboratory data were collected to evaluate the progression of chronic kidney disease (CKD) .

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
272 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Higher Risk of Kidney Function Decline With Entecavir Than Tenofovir Alafenamide in Patients With HBV Related Acute-on-chronic Liver Failure: Real-World Study
Actual Study Start Date :
May 1, 2022
Actual Primary Completion Date :
May 30, 2022
Actual Study Completion Date :
May 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: tenofovir alafenamide

tenofovir alafenamide,Gilead Sciences,capsule,25 mg,once a day,Continuous use for 48 weeks.

Drug: tenofovir alafenamide
Antiviral therapy
Experimental: entecavir

entecavir,Fujian cosunter pharmaceutical co.LTD,capsule,0.5mg,once a day,Continuous use for 48 weeks.

Drug: Entecavir
entecavir

Outcome Measures

Primary Outcome Measures

  1. the survival rates without transplantation [48 weeks]

    the survival rates without transplantation

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • the presence of hepatitis B surface antigen (HBsAg) in the serum for at least 6 months.

  • evidence of active viral replication as documented by measurable HBV DNA in the serum (≥2000IU/mL).

Exclusion Criteria:

  • Less than 18 years old.

  • history of ESKD or kidney transplantation.

  • unknown baseline estimated glomerular filtration rate (eGFR).

  • coexistence with other liver diseases such as alcoholic liver disease, autoimmune hepatitis, drug-induced liver injury, or other viral infections(hepatitis A, C, and E virus or HIV infection).

  • concomitant with malignant tumor or other serious diseases affecting survival time.

  • patients with missing data. follow-up period of <48 weeks.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wenting Peng Changsha China

Sponsors and Collaborators

  • Xiangya Hospital of Central South University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier:
NCT05453448
Other Study ID Numbers:
  • 202012708
First Posted:
Jul 12, 2022
Last Update Posted:
Jul 12, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Failure
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Tenofovir
Entecavir

Study Results

No Results Posted as of Jul 12, 2022