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

June 30, 2016 updated by: Sang Hoon Ahn, Yonsei University

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.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

253

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sang Hoon Ahn
  • Phone Number: 82-2-2228-1936
  • Email: ahnsh@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Hospital
        • Contact:
          • Jun Yong Park, M.D
          • Phone Number: +82-10-8353-0670
          • Email: drpjy@yuhs.ac
        • Principal Investigator:
          • Jun Yong Park, M.D
        • Contact:
          • Sang Hoon Ahn, M.D.Ph.D
          • Phone Number: +82-11-419-8087
          • Email: ahnsh@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peginterferon alfa-2a
Drug: Peginterferon alfa-2a
Patients will receive Peginterferon alfa-2a according to the standard medical practice

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 12 week from baseline
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
Time Frame: 12 week from baseline
12 week from baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
The change of HBV DNA at Week 12 from baseline
Time Frame: 12 week from baseline
12 week from baseline
The change of HBsAg at Week 4, 8, 12 from baseline
Time Frame: 4, 8, 12 week from baseline
4, 8, 12 week from baseline
The change of ALT at week 4, 8, 12 from baseline
Time Frame: 4, 8, 12 week 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
Time Frame: 12 week from baseline
12 week from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Sang Hoon Ahn, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimate)

July 4, 2016

Study Record Updates

Last Update Posted (Estimate)

July 4, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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