NCT04196998

Brief Summary

This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.

Trial Health

43
At Risk

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 Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

4.9 years

First QC Date

December 9, 2019

Last Update Submit

December 10, 2019

Conditions

Hepatitis BCompensated Cirrhosis

Keywords

hepatitis b viruscompensated cirrhosisnucleosidenucleotide

Outcome Measures

Primary Outcomes (1)

  • Incidence of decompensated cirrhosis

    Incidence of decompensated cirrhosis is evaluated in the follow-up

    144 week

Secondary Outcomes (8)

  • 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

  • Ratio of patients with hepatitis b virus e antigen seroconversion after treatment

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

  • Ratio of patients with undetectable hepatitis b virus surface antigen after treatment

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

  • Serum calcium

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

  • Serum phosphorus

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

  • +3 more secondary outcomes

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
  • Age from 18 to 65 years old;
  • Hepatitis b virus DNA positive;
  • Cirrhosis or portal hypertension is found through ultrasonography, computed tomography or magnetic resonance imaging;
  • Do not receive nucleotide/nucleoside analogues treatment in the past half year.

You may not qualify if:

  • Complications of decompensated cirrhosis: ascites, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, etc;
  • 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

MeSH Terms

Conditions

Hepatitis B

Interventions

entecavirTenofovirtenofovir alafenamide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

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

December 9, 2019

First Posted

December 12, 2019

Study Start

January 1, 2019

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 12, 2019

Record last verified: 2019-12

Locations

CN(1)