An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B

A MULTICENTER, PROSPECTIVE, OBSERVATIONAL, NON-INTERVENTIONAL COHORT STUDY IN CHINESE SUBJECTS WITH HBeAg NEGATIVE CHRONIC HEPATITIS B (CHB) RECEIVING THERAPY WITH PEGINTERFERON ALFA

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01730508

Enrollment

978

Registered

2012-11-21

Start date

2012-11-20

Completion date

2017-06-25

Last updated

2017-07-14

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

Conditions

Hepatitis B, Chronic

Brief summary

This multicenter, prospective, observational study will evaluate the use in clinical practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with HBeAg negative chronic hepatitis B. Participants receiving Pegasys according to the local label will be followed for the duration of their treatment and for one year after cessation of treatment.

Interventions

DRUGPegylated Interferon Alfa (Peginterferon Alfa)

Peginterferon alfa dosing and treatment duration are at the discretion of the investigator in accordance with China clinical practice and local labeling.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult participants, \>/= 18 years of age * Treatment with Pegasys according to label and standard clinical practice * HBeAg negative serologically proven chronic hepatitis B with or without cirrhosis * Serum alanine aminotransferase (ALT) \> upper limit of normal (ULN) but \</= 10 x ULN * Hepatitis B Virus (HBV) DNA \>/= 2000 IU/mL

Exclusion criteria

* Contraindications to Pegasys as detailed in the label * Co-infection with hepatitis A, hepatitis C or HIV * Pregnant or lactating women * Participants should not receive concomitant therapy with telbivudine

Design outcomes

Primary

Measure	Time frame
Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation	approximately 4 years

Secondary

Measure	Time frame
Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment	approximately 4 years
Incidence of HBsAg loss/seroconversion	approximately 4 years
Incidence of normalization of serum ALT levels	approximately 4 years
Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment	approximately 4 years
Clinical/demographic patient characteristics at initiation of treatment	approximately 4 years
Safety: Incidence of adverse events	approximately 4 years
Dosage/schedule of Pegasys treatment in real-life clinical setting	approximately 4 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026