NCT02973646

Brief Summary

The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic hepatitis b patients with e antigen positive based on the detection of interferon gene mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.

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
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2016

Typical duration for phase_4

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, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

November 13, 2016

Last Update Submit

November 23, 2016

Conditions

Chronic Hepatitis b

Keywords

chronic hepatitis bpeginterferon alfa-2binterferon gene mutationinterferon receptor

Outcome Measures

Primary Outcomes (1)

  • good virologic response

    level of HBsAg is less than or equal to 1500 IU/ml

    24th week

Secondary Outcomes (2)

  • common virologic response

    24th week

  • bad virologic response

    24th week

Study Arms (2)

Nucleos(t)ide analogues treatment

EXPERIMENTAL

Patients with interferon receptor level down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 24th week, then nucleos(t)ide analogues (entecavir tablet 0.5mg/d or tenofovir tablet 300mg/d) from 25th to 36th week, then peginterferon alfa-2b injection 80ug/d again from 36th to 48th week.

Drug: Entecavir or TenofovirDrug: Peginterferon Alfa-2B

Peginterferon treatment

ACTIVE COMPARATOR

Patients with interferon receptor level not down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 48th week.

Drug: Peginterferon Alfa-2B

Interventions

Entecavir or TenofovirDRUG

Patients in nucleos(t)ide analogues treatment for 12 weeks group will receive nucleos(t)ide analogs therapy (Entecavir tablet 0.5mg/d or Tenofovir tablet 300mg/d) from Week 25th to 36th.

Also known as: Baraclude, Viread
Nucleos(t)ide analogues treatment
Peginterferon Alfa-2BDRUG
Nucleos(t)ide analogues treatmentPeginterferon treatment

Eligibility Criteria

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

You may qualify if:

  • Chronic hepatitis b Patients who should receive anti-HBV therapy according to guideline and are willing to receive interferon therapy;
  • Hepatitis B e antigen positive.

You may not qualify if:

  • Patients received anti-HBV therapy in the past 6 months;
  • Patients with liver cirrhosis or hepatocellular carcinoma or other malignancies;
  • Patients with other factors causing active liver diseases;
  • Pregnancy or lactation women;
  • Patients with HIV infection or congenital immune deficiency diseases;
  • Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications.
  • Patients with other reasons not suitable to receive interferon therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavirTenofovirpeginterferon alfa-2b

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, Master

CONTACT

+8613760783281xwx1983@163.com

Liang Peng, Doctor

CONTACT

+8613533978874pzp33@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

November 13, 2016

First Posted

November 25, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

CN(1)