Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B. (POTENT)

July 1, 2011 updated by: Hanyang University

A Randomized, Multi Center, Phase IIIb Open-label Study to Evaluate the Efficacy of Sequential Therapy of Peginterferon Alfa-2a(Pegasys(TM)) Following Entercavir Compared With Peginterferon Alfa-2a Monotherapy in Patient With HBeAg Positive Chronic Hepatitis B.

Evaluate the safety and efficacy of Peginterferon alfa-2a following Entecavir compared with Peginterferon alfa-2a monotherapy in patient with HBeAg positive chronic hepatitis B.

  • Increased HBeAg seroconversion rate
  • Increased HBsAg loss rate
  • To define the best treatment condition for chronic HBV hepatitis patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 612-030
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Contact:
        • Principal Investigator:
          • Seung-Ha Park, MD, Ph.D
      • Busan, Korea, Republic of, 602-702
        • Recruiting
        • Kosin University Gospel Hospital
        • Contact:
        • Principal Investigator:
          • Byung-Cheol Yun, MD, Ph.D
      • Busan, Korea, Republic of, 602-103
        • Recruiting
        • Dong-A University Medical Center
        • Contact:
        • Principal Investigator:
          • Sungwook Lee, MD, Ph.D
      • Daegu, Korea, Republic of, 700-721
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
          • Won-young Tak, MD, Ph.D
          • Phone Number: +82-53-420-5114
          • Email: wytak@knu.ac.kr
        • Principal Investigator:
          • Won-Young Tak, MD, Ph.D
      • Daegu, Korea, Republic of, 705-717
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
          • Heon-Ju Lee, MD, Ph.D
          • Phone Number: +82-53-623-8001
          • Email: hjlee@ymu.ac.kr
        • Principal Investigator:
          • Heon-Ju Lee, MD, Ph.D
      • Seoul, Korea, Republic of, 110-746
        • Recruiting
        • Kangbuk Samsung Hospital
        • Contact:
        • Principal Investigator:
          • Byung-Ik Kim, MD, Ph.D
      • Seoul, Korea, Republic of, 130-702
        • Recruiting
        • Kyunghee University Medical Center
        • Contact:
          • Byung-Ho Kim, MD, Ph.D
          • Phone Number: +82-2-958-8114
          • Email: kimbh@khu.ac.kr
        • Principal Investigator:
          • Byung-Ho Kim, MD, Ph.D
      • Seoul, Korea, Republic of, 133-791
        • Recruiting
        • Hanyang University Hospital
        • Contact:
        • Principal Investigator:
          • Dae-Won Jun, MD, Ph.D
      • Seoul, Korea, Republic of, 134-701
        • Recruiting
        • Kangdong Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Hyoung-Su Kim, MD, MS
      • Seoul, Korea, Republic of, 135-720
        • Recruiting
        • Kangnam Severance Hospital
        • Contact:
        • Principal Investigator:
          • Ja-Kyung Kim, MD, Ph.D
      • Seoul, Korea, Republic of, 139-707
        • Recruiting
        • Inje University Sanggye Paik Hospital
        • Contact:
        • Principal Investigator:
          • Won-Choong Choi, MD, Ph.D
      • Seoul, Korea, Republic of, 143-729
        • Recruiting
        • Konkuk University Medical Center
        • Contact:
        • Principal Investigator:
          • So-Young Kwon, MD, Ph.D
    • Chungcheongnam-do
      • Cheonan, Chungcheongnam-do, Korea, Republic of, 330-715
        • Recruiting
        • Dankook University Hospital
        • Contact:
        • Principal Investigator:
          • Il-Han Song, MD, Ph.D
    • Gangwon-do
      • Chuncheon, Gangwon-do, Korea, Republic of, 200-704
        • Recruiting
        • Chuncheon Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Dong-Joon Kim, MD, Ph.D
      • Wonju, Gangwon-do, Korea, Republic of, 220-701
        • Recruiting
        • Wonju Christian Hospital
        • Contact:
        • Principal Investigator:
          • Soon Koo Baik, MD, Ph.D
    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
        • Recruiting
        • Soon Chun Hyang University Bucheon Hospital
        • Contact:
        • Principal Investigator:
          • Sang-Gyune Kim, MD, MS
      • Guri, Gyeonggi-do, Korea, Republic of, 471-854
        • Recruiting
        • Hanyang University Guri Hospital
        • Contact:
        • Principal Investigator:
          • Joo Hyun Sohn, MD, Ph.D
      • Sungnam, Gyeonggi-do, Korea, Republic of, 463-712
        • Recruiting
        • Bundang CHA Medical Center
        • Contact:
        • Principal Investigator:
          • Seong-Gyu Hwang, MD, Ph.D
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, Korea, Republic of, 626-770
        • Recruiting
        • Busan National University Yangsan Hospital
        • Contact:
        • Principal Investigator:
          • Ki-Tae Yoon, MD, MS
    • Jeju-do
      • Jeju, Jeju-do, Korea, Republic of, 690-767
        • Recruiting
        • Jeju National University Hospital
        • Contact:
        • Principal Investigator:
          • Byung-Cheol Song, MD, Ph.D

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic hepatitis B patients with HBeAg positive, HBsAg positive, HBV DNA > 100,000 copies/ml and anti-HBs negative, serum ALT exceeding 2 X ULN but less than 10 X ULN.

Exclusion Criteria:

  • Patient infected concurrently with HCV, HDV and HIV or patient with a history of antiviral treatment for Hepatitis B or patient with hepatic decompensation.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequential therapy
Entecavir/Baraclude(TM), 0.5mg, oral administration, once daily, for the first 12 weeks Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, from week 4 to 52 for 48 weeks
Drug: Entecavir and Pegylated interferon α-2a Sequential Treatment Group
Entecavir/Baraclude(TM), 0.5mg, oral administration, once daily, for the first 12 weeks Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, from week 4 to 52 for 48 weeks
Other Names:
  • Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM)
  • Generic/Brand name: Entecavir/Baraclude(TM)
Active Comparator: Peginterferon alfa-2a monotherapy
Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
Drug: Pegylated interferon α-2a Monotreatment Group
Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
Other Names:
  • Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
HBeAg seroconversion
Time Frame: 24 weeks after treatment
24 weeks after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
the change of HBsAg titer
Time Frame: 24 weeks after treatment
24 weeks after treatment
the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml
Time Frame: 24 weeks after treatment
24 weeks after treatment
The rate of serum HBV DNA < 300 copies
Time Frame: 24 weeks after treatment
24 weeks after treatment
The rate of ALT normalization
Time Frame: 24 weeks after treatment
24 weeks after treatment
The rate of HBsAg loss
Time Frame: 24 weeks after treatment
24 weeks after treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hanyang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Pharma AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joo Hyun Sohn, MD, Ph.D, Hanyang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 4, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML25206

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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Conditions

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