NCT03919565

Brief Summary

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment naive patients with HBV related liver fibrosis.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration 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

February 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

2.7 years

First QC Date

April 16, 2019

Last Update Submit

April 17, 2019

Conditions

Hepatitis BLiver Fibrosis

Keywords

hepatitis b viruspeginterferon alfaliver fibrosis

Outcome Measures

Primary Outcomes (1)

  • Change of level of liver fibrosis after anti-virus treatment

    Liver biopsy or fibroscan would be accessed to know the change of level of liver fibrosis at 48 and 144 weeks after anti-virus treatment.

    48 week, 144 week

Secondary Outcomes (3)

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

    24 week, 48 week, 72 week, 96 week, 120 week,144 week

  • Ratio of patients with hepatitis B e antigen seroconversion after anti-virus treatment

    24 week, 48 week, 72 week, 96 week, 120 week,144 week

  • Ratio of patients with hepatitis b surface antigen seroconversion after anti-virus treatment

    24 week, 48 week, 72 week, 96 week, 120 week,144 week

Study Arms (2)

TDF group

ACTIVE COMPARATOR

80 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 144 weeks.

Drug: Tenofovir Disoproxil Fumarate

Peginterferon alfa group

EXPERIMENTAL

40 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg or peginterferon alfa 2b 80μg once per week from baseline to 48 weeks. Then they would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from 49 to 144 weeks.

Drug: Peginterferon Alfa-2aDrug: Peginterferon Alfa-2b

Interventions

Tenofovir Disoproxil FumarateDRUG

Patients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day.

Also known as: Viread
TDF group
Peginterferon Alfa-2aDRUG

Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.

Also known as: Pegasys
Peginterferon alfa group
Peginterferon Alfa-2bDRUG

Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.

Also known as: Pegintron
Peginterferon alfa group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
  • Age from 18 to 55 years old;
  • Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan;
  • Portal vein diameter ≤ 12 mm from liver ultrasound;
  • Without treatment of anti-virus treatment ever before.

You may not qualify if:

  • Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
  • Pregnancy or lactation;
  • Other active liver diseases；
  • Human immunodeficiency virus infection or congenital immune deficiency diseases;
  • Severe diabetes, autoimmune diseases;
  • Other important organ dysfunctions;
  • Patients can not follow-up.

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 BLiver Cirrhosis

Interventions

Tenofovirpeginterferon alfa-2apeginterferon alfa-2b

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesFibrosisPathologic 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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 18, 2019

Study Start

February 1, 2019

Primary Completion

October 31, 2021

Study Completion

December 31, 2021

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations

CN(1)