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.

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: Unknown
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Drug: Entecavir and Pegylated interferon α-2a Sequential Treatment Group; Drug: Pegylated interferon α-2a Monotreatment Group

• Study Type: Interventional
• Enrollment (Anticipated): 228
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Joo Hyun Sohn, MD, Ph.D; Phone Number: +82-31-560-2225; Email: sonjh@hanyang.ac.kr
• Study Contact Backup: Name: Dae-Won Jun, MD, Ph.D; Phone Number: +82-2-2290-8338; Email: noshin@hanyang.ac.kr

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 612-030
    • Recruiting
    • Inje University Haeundae Paik Hospital
    • Contact: Seung-ha Park, MD, Ph.D; Phone Number: +82-51-797-0100; Email: obgyy@medimail.co.kr
    • Principal Investigator: Seung-Ha Park, MD, Ph.D
  • Busan, Korea, Republic of, 602-702
    • Recruiting
    • Kosin University Gospel Hospital
    • Contact: Byung-cheol Yun, MD, Ph.D; Phone Number: +82-51-990-6114; Email: ybchepa@ns.kosinmed.or.kr
    • Principal Investigator: Byung-Cheol Yun, MD, Ph.D
  • Busan, Korea, Republic of, 602-103
    • Recruiting
    • Dong-A University Medical Center
    • Contact: Sungwook Lee, MD, Ph.D; Phone Number: +82-51-240-2400; Email: sunglee@dau.ac.kr
    • 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: Byung-Ik Kim, MD, Ph.D; Phone Number: 82-2-2001-2050; Email: bik.kim@samsung.com
    • 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: Dae-Won Jun, MD, Ph.D; Phone Number: +82-2-2290-8338; Email: noshin@hanyang.ac.kr
    • Principal Investigator: Dae-Won Jun, MD, Ph.D
  • Seoul, Korea, Republic of, 134-701
    • Recruiting
    • Kangdong Sacred Heart Hospital
    • Contact: Hyoung-Su Kim, MD, MS; Phone Number: +82-2224-2562; Email: hskim@hallym.or.kr
    • Principal Investigator: Hyoung-Su Kim, MD, MS
  • Seoul, Korea, Republic of, 135-720
    • Recruiting
    • Kangnam Severance Hospital
    • Contact: Ja-Kyung Kim, MD, Ph.D; Phone Number: +82-2-2019-2330; Email: ceciliak@yuhs.ac
    • Principal Investigator: Ja-Kyung Kim, MD, Ph.D
  • Seoul, Korea, Republic of, 139-707
    • Recruiting
    • Inje University Sanggye Paik Hospital
    • Contact: Won-Choong Choi, MD, Ph.D; Phone Number: +82-2-950-1001; Email: wcc829@paik.ac.kr
    • Principal Investigator: Won-Choong Choi, MD, Ph.D
  • Seoul, Korea, Republic of, 143-729
    • Recruiting
    • Konkuk University Medical Center
    • Contact: so young Kwon, MD, Ph.D; Phone Number: +82-2-2030-7070; Email: sykwonmd@hotmail.com
    • Principal Investigator: So-Young Kwon, MD, Ph.D
  • Chungcheongnam-do
    • Cheonan, Chungcheongnam-do, Korea, Republic of, 330-715
      • Recruiting
      • Dankook University Hospital
      • Contact: Il-Han Song, MD, Ph.D; Phone Number: +82-41-550-6694; Email: ihsong21@dankook.ac.kr
      • Principal Investigator: Il-Han Song, MD, Ph.D
  • Gangwon-do
    • Chuncheon, Gangwon-do, Korea, Republic of, 200-704
      • Recruiting
      • Chuncheon Sacred Heart Hospital
      • Contact: Dong-Joon Kim, MD, Ph.D; Phone Number: +82-33-240-5646; Email: djkim@hallym.ac.kr
      • Principal Investigator: Dong-Joon Kim, MD, Ph.D
    • Wonju, Gangwon-do, Korea, Republic of, 220-701
      • Recruiting
      • Wonju Christian Hospital
      • Contact: Soon Koo Baik, MD, Ph.D; Phone Number: +82-33-741-0114; Email: paiksk@yonsei.ac.kr
      • 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: Sang-gyune Kim, MD, MS; Phone Number: +82-32-621-5114; Email: mcnulty@schbc.ac.kr
      • Principal Investigator: Sang-Gyune Kim, MD, MS
    • Guri, Gyeonggi-do, Korea, Republic of, 471-854
      • Recruiting
      • Hanyang University GURI Hospital
      • Contact: Joo Hyun Sohn, MD, Ph.D; Phone Number: +82-31-560-2225; Email: sonjh@hanyang.ac.kr
      • Principal Investigator: Joo Hyun Sohn, MD, Ph.D
    • Sungnam, Gyeonggi-do, Korea, Republic of, 463-712
      • Recruiting
      • Bundang Cha Medical Center
      • Contact: Seong-Gyu Hwang, MD, Ph.D; Phone Number: +82-31-780-5000; Email: sghwang@cha.ac.kr
      • 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: Ki-Tae Yoon, MD, MS; Phone Number: 82-55-360-1412; Email: ktyoon@pnuyh.co.kr
      • Principal Investigator: Ki-Tae Yoon, MD, MS
  • Jeju-do
    • Jeju, Jeju-do, Korea, Republic of, 690-767
      • Recruiting
      • Jeju National University Hospital
      • Contact: Byung-Cheol Song, MD, Ph.D; Phone Number: +82-64-717-1114; Email: drsong@cheju.ac.kr
      • Principal Investigator: Byung-Cheol Song, MD, Ph.D

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
HBeAg seroconversion	24 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hanyang University
• Collaborators: Roche Pharma AG
• Investigators: Principal Investigator: Joo Hyun Sohn, MD, Ph.D, Hanyang University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: October 13, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimate): October 14, 2010

Study Record Updates

• Last Update Posted (Estimate): July 4, 2011
• Last Update Submitted That Met QC Criteria: July 1, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Peginterferon alfa-2a; Entecavir
• Other Study ID Numbers: ML25206