NCT02745704

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 Apr 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

April 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

April 11, 2016

Last Update Submit

January 12, 2019

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis Bpeginterferon alfa

Outcome Measures

Primary Outcomes (2)

  • HBsAg Clearance

    Percentage of Participants with HBsAg negative.

    72 weeks

  • HBsAg Seroconversion

    Percentage of Participants with HBsAg negative and anti-HBsAg positive.

    72 weeks

Study Arms (2)

PEG-IFN group

EXPERIMENTAL

Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg \<1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks.

Drug: Peginterferon alfa

NAs group

NO INTERVENTION

Patients do not need to change their NAs treatment.

Interventions

Peginterferon alfaDRUG

peginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week

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 NAs for more than 12 months.
  • Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
  • Hepatitis B surface antigen (HBsAg) positive and \<1500 IU/mL.
  • Hepatitis B virus DNA not detectable(Roche Cobas).

You may not qualify if:

  • Patients with liver cirrhosis, Hepatocellular Carcinoma 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 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

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 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

April 11, 2016

First Posted

April 20, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

CN(1)