Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B. (POTENT)
This study is currently recruiting participants.
Verified June 2011 by Hanyang University
Sponsor:
Hanyang University
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
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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:
|
|
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
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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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, Chronic Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections |
DNA Virus Infections Interferons Peginterferon alfa-2a Interferon-alpha Entecavir Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013