NCT02908763

Brief Summary

HBsAg Loss/Seroconversion is uncommon in Low replicative chronic HBV infection patients. The purpose of this study is to investigate the ability of peginterferon alpha to achieve HBsAg loss/seroconversion therapy in Low replicative chronic HBV infection patients with Low Level HBsAg.

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
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

3.1 years

First QC Date

August 27, 2016

Last Update Submit

May 20, 2018

Conditions

Chronic Hepatitis B

Keywords

Chronic Hepatitis BPeginterferon Alpha

Outcome Measures

Primary Outcomes (1)

  • HBsAg Clearance Rate

    Percentage of Participants with HBsAg negative.

    96 weeks

Secondary Outcomes (1)

  • HBsAg Seroconversion Rate

    96 weeks

Study Arms (2)

Pegylated interferon group

EXPERIMENTAL

Low replicative chronic HBV infection patients with HBsAg \<1000 IU/ mL and HBV DNA\<2000 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

Observing Group

NO INTERVENTION

Only observing and following up in this group.

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
Pegylated interferon group

Eligibility Criteria

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

You may qualify if:

  • Hepatitis B surface antigen (HBsAg) positive and \<1000 IU/mL.
  • Hepatitis B surface antibody (HBsAb) negative.
  • Hepatitis B e antigen (HBeAg) negative.
  • Hepatitis B virus DNA \<2000 IU/mL.
  • Absence of previous antiviral therapy.

You may not qualify if:

  • Patients with active alcohol and/or drugs consumption.
  • 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 mental illness.
  • 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)

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

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 27, 2016

First Posted

September 21, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

CN(1)