NCT02893124

Brief Summary

HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response were enrolled. After giving informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. Treatment endpoint was HBsAg loss(\<0.05 IU/mL).

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 Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

3 years

First QC Date

August 28, 2016

Last Update Submit

May 20, 2018

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis B

Outcome Measures

Primary Outcomes (1)

  • HBsAg Clearance

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

    96 weeks

Secondary Outcomes (1)

  • HBsAg Seroconversion

    96 weeks

Study Arms (2)

PEG-IFN group

EXPERIMENTAL

HBeAg-negative CHB patients with HBsAg \<1000 IU/ mL and HBV DNA\<100 IU/mL are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for at most 96 weeks.

Drug: peginterferon alfa

NAs group

NO INTERVENTION

CHB patients do not need to change their NAs treatment.

Interventions

peginterferon alfaDRUG

peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week, for at most 96 weeks.

Also known as: peginterferon alfa-2a or peginterferon alfa-2b
PEG-IFN group

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 and had a history of NAs drug resistance or suboptimal/partial virological response.
  • 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 alpha feto protein (AFP) \>2 upper limit of normal(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.
  • 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)

Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2apeginterferon 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

Central Study Contacts

Xiang Zhu

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

August 28, 2016

First Posted

September 8, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

CN(1)