Brief Summary

In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test every year from the second year to the fifth year after the ending of peginterferon alfa treatment, and long-term benefit of interferon treatment will be evaluated.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

473

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach

1 country

28 active sites

Status

completed

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

4.3 years study duration

Study Start

First participant enrolled

May 18, 2016

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2020

Completed

Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

4.3 years

First QC Date

June 6, 2017

Last Update Submit

April 11, 2021

Conditions

Hepatitis B

Keywords

peginterferon alphaHBeAg seroconversionimmune control

Outcome Measures

Primary Outcomes (1)

rate of HBeAg seroconversion
from the second year to the fifth year

Secondary Outcomes (6)

decent degree of HBeAg
from the second year to the fifth year
decent degree of HBV DNA
from the second year to the fifth year
rate of alanine aminotransferase normalization
from the second year to the fifth year
rate of HBeAg loss
from the second year to the fifth year
rate of HBV DNA undetectable
from the second year to the fifth year
+1 more secondary outcomes

Study Arms (2)

peginterferon alfa 2b

Drug: Peginterferon Alfa-2B

peginterferon alfa 2a

Drug: Peginterferon Alfa-2A

Interventions

Peginterferon Alfa-2BDRUG

pre-received standard peginterferon alfa-2b therapy

Also known as: pegberon

peginterferon alfa 2b

Peginterferon Alfa-2ADRUG

pre-received standard peginterferon alfa-2a therapy

Also known as: pegasys

peginterferon alfa 2a

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with chronic hepatitis B who previously participated in TB1211IFN study.

You may qualify if:

Understand and sign the informed consent form.
Participated in NCT01760122 study (TB1211IFN) and has received at least 39 doses of peginterferon.

You may not qualify if:

Conditions which in the opinion of the investigator should be precluded from the study(e.g., poor compliance).

Contact the study team to confirm eligibility.