Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B.
POTENT
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.
1 other identifier
interventional
228
1 country
20
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2010
Typical duration for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 13, 2010
CompletedFirst Posted
Study publicly available on registry
October 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJuly 4, 2011
June 1, 2011
3 years
October 13, 2010
July 1, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
HBeAg seroconversion
24 weeks after treatment
Secondary Outcomes (5)
the change of HBsAg titer
24 weeks after treatment
the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml
24 weeks after treatment
The rate of serum HBV DNA < 300 copies
24 weeks after treatment
The rate of ALT normalization
24 weeks after treatment
The rate of HBsAg loss
24 weeks after treatment
Study Arms (2)
Sequential therapy
EXPERIMENTALEntecavir/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
ACTIVE COMPARATORPegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
Interventions
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/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient infected concurrently with HCV, HDV and HIV or patient with a history of antiviral treatment for Hepatitis B or patient with hepatic decompensation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hanyang Universitylead
- Roche Pharma AGcollaborator
Study Sites (20)
Dong-A University Medical Center
Busan, Busan, 602-103, South Korea
Kosin University Gospel Hospital
Busan, Busan, 602-702, South Korea
Inje University Haeundae Paik Hospital
Busan, Busan, 612-030, South Korea
Dankook University Hospital
Cheonan, Chungcheongnam-do, 330-715, South Korea
Kyungpook National University Hospital
Daegu, Daegu, 700-721, South Korea
Yeungnam University Medical Center
Daegu, Daegu, 705-717, South Korea
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 200-704, South Korea
Wonju Christian Hospital
Wŏnju, Gangwon-do, 220-701, South Korea
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 420-767, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 471-854, South Korea
Bundang CHA medical center
Sungnam, Gyeonggi-do, 463-712, South Korea
Busan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 626-770, South Korea
Jeju National University Hospital
Jeju City, Jeju-do, 690-767, South Korea
Kangbuk Samsung Hospital
Seoul, Seoul, 110-746, South Korea
Kyunghee university Medical Center
Seoul, Seoul, 130-702, South Korea
Hanyang University Hospital
Seoul, Seoul, 133-791, South Korea
Kangdong Sacred Heart Hospital
Seoul, Seoul, 134-701, South Korea
Kangnam Severance Hospital
Seoul, Seoul, 135-720, South Korea
Inje University Sanggye Paik Hospital
Seoul, Seoul, 139-707, South Korea
Konkuk University Medical Center
Seoul, Seoul, 143-729, South Korea
Related Publications (1)
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.
PMID: 29998882DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joo Hyun Sohn, MD, Ph.D
Hanyang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 13, 2010
First Posted
October 14, 2010
Study Start
June 1, 2010
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
July 4, 2011
Record last verified: 2011-06