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

Phase 4

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Peginterferon alfa-2a

• Registration Number: NCT02822547
• Lead Sponsor: Yonsei University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Status Verified: 2016-06
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-06-30
• Last Update Submitted: 2016-06-30
• Study First Posted: 2016-07-04
• Last Update Posted: 2016-07-04
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 253

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peginterferon alfa-2a	Peginterferon alfa-2a	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of