NCT04195074

Brief Summary

This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of chronic hepatitis b

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
300

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

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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 5, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

5 years

First QC Date

December 5, 2019

Last Update Submit

December 15, 2019

Conditions

Chronic Hepatitis b

Keywords

chronic hepatitis bnucleosidenucleotide

Outcome Measures

Primary Outcomes (2)

  • Rate of renal function decline

    Renal function indicators mainly include blood urea nitrogen, serum creatine and estimated glomerular filtration rate, and the rate of renal function decline would be evaluated.

    144 week

  • Rate of hypercalcemia

    The serum calcium would be detected to know the ratio of patients with hypercalcemia.

    144 week

Secondary Outcomes (4)

  • hepatitis b virus(HBV) DNA undetectable rate

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

  • hepatitis b e antigen loss rate

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

  • hepatitis b s antigen loss rate

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

  • hepatitis b e antigen seroconversion rate

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

Study Arms (3)

ETV group

EXPERIMENTAL

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

Drug: Entecavir

TDF group

EXPERIMENTAL

100 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

100 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;
  • HBeAg-positive: HBV DNA≥20000IU/ml，HBeAg-negative: HBV DNA≥2000IU/ml；
  • ALT≥2×ULN；
  • 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

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavirTenofovirtenofovir alafenamide

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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 5, 2019

First Posted

December 11, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

December 17, 2019

Record last verified: 2019-12

Locations

CN(1)