NCT02838810

Brief Summary

As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.

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
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2016

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

3.5 years

First QC Date

July 16, 2016

Last Update Submit

January 12, 2019

Conditions

Chronic Hepatitis B

Keywords

peginterferon alfaChronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

  • HBsAg Clearance

    Percentage of Participants with HBsAg \<0.05 IU/mL.

    120 weeks

  • HBsAg Seroconversion

    Percentage of Participants with HBsAg \<0.05 IU/mL and anti-HBsAg positive.

    120 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

CHB patients with low level HBsAg.Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg \<1000 IU/mL and Hepatitis B virus DNA \<100 IU/mL, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.

Drug: peginterferon alfa

Control

OTHER

Patients do not need to change their NAs treatment.

Drug: Nucleoside analogues

Interventions

peginterferon alfaDRUG

peginterferon alfa-2b or peginterferon alfa-2a

Experimental
Nucleoside analoguesDRUG

Nucleoside analogues

Also known as: NAs
Control

Eligibility Criteria

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

You may qualify if:

  • CHB patients who had received single NAs for more than 12 months.
  • Hepatitis B e antigen (HBeAg)-negative.
  • Hepatitis B surface antigen (HBsAg) positive and \<1000 IU/mL.
  • Hepatitis B virus DNA \<100 IU/mL.

You may not qualify if:

  • Patients with liver cirrhosis, Hepatocellular Carcinoma or AFP \>2 ULN or other malignancies.
  • Patients with other factors causing liver diseases.
  • Pregnant and lactating women.
  • Patients with concomitant HIV infection or congenital immune deficiency diseases.
  • Patients with diabetes, autoimmune diseases.
  • Patients with important organ dysfunctions.
  • Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)
  • Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
  • Patients with a previous use of IFN anti hepatitis B virus treatment or have NAs drug resistance.
  • Patients who can't come back to clinic for follow-up on schedule.

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

nas

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

Study Officials

  • Zhiliang Gao, Doctor

    Third Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Zhu, Doctor

CONTACT

138264525640628zhuxiang@163.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
Chief director of department of infectious disease

Study Record Dates

First Submitted

July 16, 2016

First Posted

July 20, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

CN(1)