Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy

A Multi-center, Prospective Study to Acess Long-term Benefit in HBeAg Positive Chronic Hepatitis B Patients Who Previously Received Standard Peginterferon Alfa Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03181113

Enrollment

473

Registered

2017-06-08

Start date

2016-05-18

Completion date

2020-09-21

Last updated

2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

peginterferon alpha, HBeAg seroconversion, immune control

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.

Interventions

DRUGPeginterferon Alfa-2B

pre-received standard peginterferon alfa-2b therapy

DRUGPeginterferon Alfa-2A

pre-received standard peginterferon alfa-2a therapy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
rate of HBeAg seroconversion	from the second year to the fifth year

Secondary

Measure	Time frame
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
decent degree of HBeAg	from the second year to the fifth year
rate of HBV DNA undetectable	from the second year to the fifth year
rate of HBeAg seroconversion	from the second year to the fifth year
rate of HBeAg loss	from the second year to the fifth year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026