Study on Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults

Study to Identify Eligible Subjects Using Response Guided Therapy-Stopping Rule for Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02822547

Enrollment

253

Registered

2016-07-04

Start date

2015-03-31

Completion date

2016-12-31

Last updated

2016-07-04

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

Conditions

Chronic Hepatitis B

Brief summary

Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks

Interventions

DRUGPeginterferon alfa-2a

Patients will receive Peginterferon alfa-2a according to the standard medical practice

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* History of HBsAg positive for more than 6 months * HBeAg-positive or HBeAg-negative within 8 weeks * Serum AST or ALT ≥ 80 IU/L * HBe-Ag positive patients: Serum HBV DNA ≥ 1.0 X 10\^5 copies/mL (or 20,000 IU/mL) * HBeAg-negative patients: serum HBV DNA ≥ 1.0 X 10\^4 copies/mL(or 2,000 IU/mL)

Exclusion criteria

* History of antiviral therapy for Chronic hepatitis B within 6 months of study enrollment * Prior treatment of interferon * Presence of viral coinfections (hepatitis C, hepatitis delta, or human immunodeficiency virus) * Other chronic liver disease or decompensated liver disease * platelet\<90,000/mm3 or absolute neutrophil count \< 1,500 mm3 * Pregnant or lactating woman * History of Organ transplantation * Treatment with immunosuppressive/immunomodulatory agents within 6 months prior to study entry

Design outcomes

Primary

Measure	Time frame
The proportion subjects with HBsAg ≤ 20,000 IU/mL at 12 week treatment of PEG-IFN in HBeAg-positive Chronic Hepatitis B	12 week from baseline
The proportion subjects with any decline of HBsAg and/or HBV DNA decline more than 2 log copies/ml at 12 week treatment of PEG-IFN in HBeAg-negative CHB	12 week from baseline

Secondary

Measure	Time frame
The change of HBV DNA at Week 12 from baseline	12 week from baseline
The change of HBsAg at Week 4, 8, 12 from baseline	4, 8, 12 week from baseline
The change of ALT at week 4, 8, 12 from baseline	4, 8, 12 week from baseline
The proportion of HBV DNA undetectable level (< 60 IU/mL, approximately 300 copies/mL) at week 12	12 week from baseline

Countries

South Korea

Contacts

Primary ContactSang Hoon Ahn

ahnsh@yuhs.ac82-2-2228-1936

Outcome results

None listed

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