NCT03920618

Brief Summary

This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

5.9 years

First QC Date

April 16, 2019

Last Update Submit

November 26, 2024

Conditions

Hepatitis BAcute-On-Chronic Liver Failure

Keywords

hepatitis b virusacute-on-chronic liver failurenucleotidenucleoside

Outcome Measures

Primary Outcomes (1)

  • Survival rate in the follow-up

    Whether patients will survive after treatment is observed in the follow-up.

    144 week

Secondary Outcomes (2)

  • Model for end-stage liver disease (MELD) score is recorded after treatment

    0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week

  • Ratio of patients with undetectable hepatitis b virus DNA after treatment

    4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week

Study Arms (3)

ETV group

ACTIVE COMPARATOR

50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.

Drug: Entecavir

TDF group

ACTIVE COMPARATOR

50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.

Drug: Tenofovir Disoproxil Fumarate

TAF group

EXPERIMENTAL

50 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.

Drug: Tenofovir Alafenamide

Interventions

EntecavirDRUG

Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.

Also known as: Baraclude
ETV group
Tenofovir Disoproxil FumarateDRUG

Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.

Also known as: Viread
TDF group
Tenofovir AlafenamideDRUG

Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.

Also known as: Vemlidy
TAF group

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
  • Age from 12 to 65 years old;
  • Serum total bilirubin level \> 10 times upper limit of normal;
  • Prothrombin time activity \< 40% or prothrombin time international ratio \> 1.5；
  • Do not receive nucleotide/nucleoside analogues treatment in the past half year.

You may not qualify if:

  • Other active liver diseases;
  • Hepatocellular carcinoma or other malignancy;
  • Pregnancy or lactation;
  • Human immunodeficiency virus infection or congenital immune deficiency diseases;
  • Severe diabetes, autoimmune diseases;
  • Other important organ dysfunctions;
  • Using glucocorticoid;
  • Patients can not follow-up;
  • Investigator considering inappropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (1)

  • Zhang Y, Xu W, Deng Z, Wang L, Zheng X, Zhu X, Li X, Li J, Shu X, Lai J, Peng L, Xie C. Long-term efficacy and safety of tenofovir alafenamide, tenofovir disoproxil fumarate, and entecavir in treating hepatitis B virus-related acute-on-chronic liver failure: A 144-week data analysis. Liver Res. 2024 Oct 24;8(4):295-303. doi: 10.1016/j.livres.2024.10.001. eCollection 2024 Dec.

    PMID: 39958923DERIVED

MeSH Terms

Conditions

Hepatitis BAcute-On-Chronic Liver Failure

Interventions

entecavirTenofovirtenofovir alafenamide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesLiver Failure, AcuteLiver FailureHepatic Insufficiency

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Liang Peng, Doctor

    Third Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenxiong Xu, Doctor

CONTACT

+8613760783281xwx1983@163.com

Liang Peng, Doctor

CONTACT

+8613533978874pzp33@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professer

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 19, 2019

Study Start

February 21, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Locations

CN(1)