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

Primary Purpose

Chronic Hepatitis B

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Peginterferon alfa-2a

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peginterferon alfa-2a

Arm Description

Outcomes

Primary Outcome Measures

The proportion subjects with HBsAg ≤ 20,000 IU/mL at 12 week treatment of PEG-IFN in HBeAg-positive Chronic Hepatitis B

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

Secondary Outcome Measures

The change of HBV DNA at Week 12 from baseline

The change of HBsAg at Week 4, 8, 12 from baseline

The change of ALT at week 4, 8, 12 from baseline

The proportion of HBV DNA undetectable level (< 60 IU/mL, approximately 300 copies/mL) at week 12

Full Information

NCT ID

NCT02822547

First Posted

June 30, 2016

Last Updated

June 30, 2016

Sponsor

Yonsei University

Collaborators

Roche Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT02822547

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yonsei University

Collaborators

Roche Pharma AG

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

253 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Peginterferon alfa-2a

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Peginterferon alfa-2a

Intervention Description

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

Primary Outcome Measure Information:

Title

The proportion subjects with HBsAg ≤ 20,000 IU/mL at 12 week treatment of PEG-IFN in HBeAg-positive Chronic Hepatitis B

Time Frame

12 week from baseline

Title

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

Time Frame

12 week from baseline

Secondary Outcome Measure Information:

Title

The change of HBV DNA at Week 12 from baseline

Time Frame

12 week from baseline

Title

The change of HBsAg at Week 4, 8, 12 from baseline

Time Frame

4, 8, 12 week from baseline

Title

The change of ALT at week 4, 8, 12 from baseline

Time Frame

4, 8, 12 week from baseline

Title

The proportion of HBV DNA undetectable level (< 60 IU/mL, approximately 300 copies/mL) at week 12

Time Frame

12 week from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sang Hoon Ahn

Phone

82-2-2228-1936

ahnsh@yuhs.ac

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang Hoon Ahn

Organizational Affiliation

Severance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sang Hoon Ahn, M.D.Ph.D

Phone

+82-11-419-8087

ahnsh@yuhs.ac

First Name & Middle Initial & Last Name & Degree

Jun Yong Park, M.D

Phone

+82-10-8353-0670

drpjy@yuhs.ac

First Name & Middle Initial & Last Name & Degree

Jun Yong Park, M.D

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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