Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B.
NCT ID: NCT01220596
Last Updated: 2011-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
228 participants
INTERVENTIONAL
2010-06-30
2013-06-30
Brief Summary
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* Increased HBeAg seroconversion rate
* Increased HBsAg loss rate
* To define the best treatment condition for chronic HBV hepatitis patients
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
Peginterferon alfa-2a monotherapy
Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
Pegylated interferon α-2a Monotreatment Group
Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
Interventions
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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
Pegylated interferon α-2a Monotreatment Group
Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Hanyang University
OTHER
Responsible Party
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Hanyang University
Principal Investigators
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Joo Hyun Sohn, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Locations
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Dong-A University Medical Center
Busan, Busan, South Korea
Kosin University Gospel Hospital
Busan, Busan, South Korea
Inje University Haeundae Paik Hospital
Busan, Busan, South Korea
Dankook University Hospital
Cheonan, Chungcheongnam-do, South Korea
Kyungpook National University Hospital
Daegu, Daegu, South Korea
Yeungnam University Medical Center
Daegu, Daegu, South Korea
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea
Wonju Christian Hospital
Wŏnju, Gangwon-do, South Korea
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Bundang CHA medical center
Sungnam, Gyeonggi-do, South Korea
Busan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Jeju National University Hospital
Jeju City, Jeju-do, South Korea
Kangbuk Samsung Hospital
Seoul, Seoul, South Korea
Kyunghee university Medical Center
Seoul, Seoul, South Korea
Hanyang University Hospital
Seoul, Seoul, South Korea
Kangdong Sacred Heart Hospital
Seoul, Seoul, South Korea
Kangnam Severance Hospital
Seoul, Seoul, South Korea
Inje University Sanggye Paik Hospital
Seoul, Seoul, South Korea
Konkuk University Medical Center
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Jun DW, Ahn SB, Kim TY, Sohn JH, Kim SG, Lee SW, Kim BH, Kim DJ, Kim JK, Kim HS, Hwang SG, Choi WC, Tak WY, Lee HJ, Yoon KT, Yun BC, Lee SW, Baik SK, Park SH, Park JW, Park SJ, Lee JS. Efficacy of Pegylated Interferon Monotherapy versus Sequential Therapy of Entecavir and Pegylated Interferon in Hepatitis B e Antigen-Positive Hepatitis B Patients: A Randomized, Multicenter, Phase IIIb Open-Label Study (POTENT Study). Chin Med J (Engl). 2018 Jul 20;131(14):1645-1651. doi: 10.4103/0366-6999.235880.
Other Identifiers
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ML25206
Identifier Type: -
Identifier Source: org_study_id
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