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

Primary Purpose

Antiviral Drugs

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tenofovir alafenamide
Entecavir
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antiviral Drugs

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wenting Peng

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

tenofovir alafenamide

entecavir

Arm Description

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

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

Outcomes

Primary Outcome Measures

the survival rates without transplantation
the survival rates without transplantation

Secondary Outcome Measures

Full Information

First Posted
June 27, 2022
Last Updated
July 10, 2022
Sponsor
Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT05453448
Brief Title
The Renal Safety of Tenofovir Alafenamide in HBV-related Acute-on-chronic Liver Failure: Real-World Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antiviral Drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tenofovir alafenamide
Arm Type
Experimental
Arm Description
tenofovir alafenamide,Gilead Sciences,capsule,25 mg,once a day,Continuous use for 48 weeks.
Arm Title
entecavir
Arm Type
Experimental
Arm Description
entecavir,Fujian cosunter pharmaceutical co.LTD,capsule,0.5mg,once a day,Continuous use for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
tenofovir alafenamide
Intervention Description
Antiviral therapy
Intervention Type
Drug
Intervention Name(s)
Entecavir
Intervention Description
entecavir
Primary Outcome Measure Information:
Title
the survival rates without transplantation
Description
the survival rates without transplantation
Time Frame
48 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Wenting Peng
City
Changsha
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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