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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Hanyang University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Hanyang University
ClinicalTrials.gov Identifier:
NCT01220596
First received: October 13, 2010
Last updated: July 1, 2011
Last verified: June 2011
  Purpose

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

Condition Intervention Phase
Hepatitis B, Chronic
Drug: Entecavir and Pegylated interferon α-2a Sequential Treatment Group
Drug: Pegylated interferon α-2a Monotreatment Group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hanyang University:

Primary Outcome Measures:
  • HBeAg seroconversion [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the change of HBsAg titer [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
  • the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
  • The rate of serum HBV DNA < 300 copies [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
  • The rate of ALT normalization [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
  • The rate of HBsAg loss [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 228
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220596

Contacts
Contact: Joo Hyun Sohn, MD, Ph.D +82-31-560-2225 sonjh@hanyang.ac.kr
Contact: Dae-Won Jun, MD, Ph.D +82-2-2290-8338 noshin@hanyang.ac.kr

Locations
Korea, Republic of
Dankook University Hospital Recruiting
Cheonan, Chungcheongnam-do, Korea, Republic of, 330-715
Contact: Il-Han Song, MD, Ph.D    +82-41-550-6694    ihsong21@dankook.ac.kr   
Principal Investigator: Il-Han Song, MD, Ph.D         
Chuncheon Sacred Heart Hospital Recruiting
Chuncheon, Gangwon-do, Korea, Republic of, 200-704
Contact: Dong-Joon Kim, MD, Ph.D    +82-33-240-5646    djkim@hallym.ac.kr   
Principal Investigator: Dong-Joon Kim, MD, Ph.D         
Wonju Christian Hospital Recruiting
Wonju, Gangwon-do, Korea, Republic of, 220-701
Contact: Soon Koo Baik, MD, Ph.D    +82-33-741-0114    paiksk@yonsei.ac.kr   
Principal Investigator: Soon Koo Baik, MD, Ph.D         
Soon Chun Hyang University Bucheon Hospital Recruiting
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
Contact: Sang-gyune Kim, MD, MS    +82-32-621-5114    mcnulty@schbc.ac.kr   
Principal Investigator: Sang-Gyune Kim, MD, MS         
Hanyang University Guri Hospital Recruiting
Guri, Gyeonggi-do, Korea, Republic of, 471-854
Contact: Joo Hyun Sohn, MD, Ph.D    +82-31-560-2225    sonjh@hanyang.ac.kr   
Principal Investigator: Joo Hyun Sohn, MD, Ph.D         
Bundang CHA medical center Recruiting
Sungnam, Gyeonggi-do, Korea, Republic of, 463-712
Contact: Seong-Gyu Hwang, MD, Ph.D    +82-31-780-5000    sghwang@cha.ac.kr   
Principal Investigator: Seong-Gyu Hwang, MD, Ph.D         
Busan National University Yangsan Hospital Recruiting
Yangsan, Gyeongsangnam-do, Korea, Republic of, 626-770
Contact: Ki-Tae Yoon, MD, MS    82-55-360-1412    ktyoon@pnuyh.co.kr   
Principal Investigator: Ki-Tae Yoon, MD, MS         
Jeju National University Hospital Recruiting
Jeju, Jeju-do, Korea, Republic of, 690-767
Contact: Byung-Cheol Song, MD, Ph.D    +82-64-717-1114    drsong@cheju.ac.kr   
Principal Investigator: Byung-Cheol Song, MD, Ph.D         
Dong-A University Medical Center Recruiting
Busan, Korea, Republic of, 602-103
Contact: Sungwook Lee, MD, Ph.D    +82-51-240-2400    sunglee@dau.ac.kr   
Principal Investigator: Sungwook Lee, MD, Ph.D         
Inje University Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of, 612-030
Contact: Seung-ha Park, MD, Ph.D    +82-51-797-0100    obgyy@medimail.co.kr   
Principal Investigator: Seung-Ha Park, MD, Ph.D         
Kosin University Gospel Hospital Recruiting
Busan, Korea, Republic of, 602-702
Contact: Byung-cheol Yun, MD, Ph.D    +82-51-990-6114    ybchepa@ns.kosinmed.or.kr   
Principal Investigator: Byung-Cheol Yun, MD, Ph.D         
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 700-721
Contact: Won-young Tak, MD, Ph.D    +82-53-420-5114    wytak@knu.ac.kr   
Principal Investigator: Won-Young Tak, MD, Ph.D         
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of, 705-717
Contact: Heon-Ju Lee, MD, Ph.D    +82-53-623-8001    hjlee@ymu.ac.kr   
Principal Investigator: Heon-Ju Lee, MD, Ph.D         
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 143-729
Contact: so young Kwon, MD, Ph.D    +82-2-2030-7070    sykwonmd@hotmail.com   
Principal Investigator: So-Young Kwon, MD, Ph.D         
Inje University Sanggye Paik Hospital Recruiting
Seoul, Korea, Republic of, 139-707
Contact: Won-Choong Choi, MD, Ph.D    +82-2-950-1001    wcc829@paik.ac.kr   
Principal Investigator: Won-Choong Choi, MD, Ph.D         
Kyunghee university Medical Center Recruiting
Seoul, Korea, Republic of, 130-702
Contact: Byung-Ho Kim, MD, Ph.D    +82-2-958-8114    kimbh@khu.ac.kr   
Principal Investigator: Byung-Ho Kim, MD, Ph.D         
Kangdong Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of, 134-701
Contact: Hyoung-Su Kim, MD, MS    +82-2224-2562    hskim@hallym.or.kr   
Principal Investigator: Hyoung-Su Kim, MD, MS         
Hanyang University Hospital Recruiting
Seoul, Korea, Republic of, 133-791
Contact: Dae-Won Jun, MD, Ph.D    +82-2-2290-8338    noshin@hanyang.ac.kr   
Principal Investigator: Dae-Won Jun, MD, Ph.D         
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 110-746
Contact: Byung-Ik Kim, MD, Ph.D    82-2-2001-2050    bik.kim@samsung.com   
Principal Investigator: Byung-Ik Kim, MD, Ph.D         
Kangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Ja-Kyung Kim, MD, Ph.D    +82-2-2019-2330    ceciliak@yuhs.ac   
Principal Investigator: Ja-Kyung Kim, MD, Ph.D         
Sponsors and Collaborators
Hanyang University
Roche Pharma AG
Investigators
Principal Investigator: Joo Hyun Sohn, MD, Ph.D Hanyang University
  More Information

No publications provided

Responsible Party: Joo Hyun Sohn / Professor, Hanyang University
ClinicalTrials.gov Identifier: NCT01220596     History of Changes
Other Study ID Numbers: ML25206
Study First Received: October 13, 2010
Last Updated: July 1, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Hepatitis, Viral, Human
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Entecavir
Interferon-alpha
Interferons
Peginterferon alfa-2a
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014