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

Primary Purpose

Hepatitis B, Chronic

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Entecavir and Pegylated interferon α-2a Sequential Treatment Group
Pegylated interferon α-2a Monotreatment Group
Sponsored by
Hanyang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dankook University HospitalRecruiting
  • Chuncheon Sacred Heart HospitalRecruiting
  • Wonju Christian HospitalRecruiting
  • Soon Chun Hyang University Bucheon HospitalRecruiting
  • Hanyang University Guri HospitalRecruiting
  • Bundang CHA medical centerRecruiting
  • Busan National University Yangsan HospitalRecruiting
  • Jeju National University HospitalRecruiting
  • Dong-A University Medical CenterRecruiting
  • Kosin University Gospel HospitalRecruiting
  • Inje University Haeundae Paik HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Yeungnam University Medical CenterRecruiting
  • Kangbuk Samsung HospitalRecruiting
  • Kyunghee university Medical CenterRecruiting
  • Hanyang University HospitalRecruiting
  • Kangdong Sacred Heart HospitalRecruiting
  • Kangnam Severance HospitalRecruiting
  • Inje University Sanggye Paik HospitalRecruiting
  • Konkuk University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sequential therapy

Peginterferon alfa-2a monotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

HBeAg seroconversion

Secondary Outcome Measures

the change of HBsAg titer
the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml
The rate of serum HBV DNA < 300 copies
The rate of ALT normalization
The rate of HBsAg loss

Full Information

First Posted
October 13, 2010
Last Updated
July 1, 2011
Sponsor
Hanyang University
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT01220596
Brief Title
Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B.
Acronym
POTENT
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hanyang University
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequential therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Peginterferon alfa-2a monotherapy
Arm Type
Active Comparator
Arm Description
Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
Intervention Type
Drug
Intervention Name(s)
Entecavir and Pegylated interferon α-2a Sequential Treatment Group
Other Intervention Name(s)
Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM), Generic/Brand name: Entecavir/Baraclude(TM)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Pegylated interferon α-2a Monotreatment Group
Other Intervention Name(s)
Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM)
Intervention Description
Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
Primary Outcome Measure Information:
Title
HBeAg seroconversion
Time Frame
24 weeks after treatment
Secondary Outcome Measure Information:
Title
the change of HBsAg titer
Time Frame
24 weeks after treatment
Title
the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml
Time Frame
24 weeks after treatment
Title
The rate of serum HBV DNA < 300 copies
Time Frame
24 weeks after treatment
Title
The rate of ALT normalization
Time Frame
24 weeks after treatment
Title
The rate of HBsAg loss
Time Frame
24 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joo Hyun Sohn, MD, Ph.D
Phone
+82-31-560-2225
Email
sonjh@hanyang.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Dae-Won Jun, MD, Ph.D
Phone
+82-2-2290-8338
Email
noshin@hanyang.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo Hyun Sohn, MD, Ph.D
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dankook University Hospital
City
Cheonan
State/Province
Chungcheongnam-do
ZIP/Postal Code
330-715
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Il-Han Song, MD, Ph.D
Phone
+82-41-550-6694
Email
ihsong21@dankook.ac.kr
First Name & Middle Initial & Last Name & Degree
Il-Han Song, MD, Ph.D
Facility Name
Chuncheon Sacred Heart Hospital
City
Chuncheon
State/Province
Gangwon-do
ZIP/Postal Code
200-704
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Joon Kim, MD, Ph.D
Phone
+82-33-240-5646
Email
djkim@hallym.ac.kr
First Name & Middle Initial & Last Name & Degree
Dong-Joon Kim, MD, Ph.D
Facility Name
Wonju Christian Hospital
City
Wonju
State/Province
Gangwon-do
ZIP/Postal Code
220-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soon Koo Baik, MD, Ph.D
Phone
+82-33-741-0114
Email
paiksk@yonsei.ac.kr
First Name & Middle Initial & Last Name & Degree
Soon Koo Baik, MD, Ph.D
Facility Name
Soon Chun Hyang University Bucheon Hospital
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
420-767
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-gyune Kim, MD, MS
Phone
+82-32-621-5114
Email
mcnulty@schbc.ac.kr
First Name & Middle Initial & Last Name & Degree
Sang-Gyune Kim, MD, MS
Facility Name
Hanyang University Guri Hospital
City
Guri
State/Province
Gyeonggi-do
ZIP/Postal Code
471-854
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo Hyun Sohn, MD, Ph.D
Phone
+82-31-560-2225
Email
sonjh@hanyang.ac.kr
First Name & Middle Initial & Last Name & Degree
Joo Hyun Sohn, MD, Ph.D
Facility Name
Bundang CHA medical center
City
Sungnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong-Gyu Hwang, MD, Ph.D
Phone
+82-31-780-5000
Email
sghwang@cha.ac.kr
First Name & Middle Initial & Last Name & Degree
Seong-Gyu Hwang, MD, Ph.D
Facility Name
Busan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
626-770
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki-Tae Yoon, MD, MS
Phone
82-55-360-1412
Email
ktyoon@pnuyh.co.kr
First Name & Middle Initial & Last Name & Degree
Ki-Tae Yoon, MD, MS
Facility Name
Jeju National University Hospital
City
Jeju
State/Province
Jeju-do
ZIP/Postal Code
690-767
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byung-Cheol Song, MD, Ph.D
Phone
+82-64-717-1114
Email
drsong@cheju.ac.kr
First Name & Middle Initial & Last Name & Degree
Byung-Cheol Song, MD, Ph.D
Facility Name
Dong-A University Medical Center
City
Busan
ZIP/Postal Code
602-103
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sungwook Lee, MD, Ph.D
Phone
+82-51-240-2400
Email
sunglee@dau.ac.kr
First Name & Middle Initial & Last Name & Degree
Sungwook Lee, MD, Ph.D
Facility Name
Kosin University Gospel Hospital
City
Busan
ZIP/Postal Code
602-702
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byung-cheol Yun, MD, Ph.D
Phone
+82-51-990-6114
Email
ybchepa@ns.kosinmed.or.kr
First Name & Middle Initial & Last Name & Degree
Byung-Cheol Yun, MD, Ph.D
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
612-030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-ha Park, MD, Ph.D
Phone
+82-51-797-0100
Email
obgyy@medimail.co.kr
First Name & Middle Initial & Last Name & Degree
Seung-Ha Park, MD, Ph.D
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won-young Tak, MD, Ph.D
Phone
+82-53-420-5114
Email
wytak@knu.ac.kr
First Name & Middle Initial & Last Name & Degree
Won-Young Tak, MD, Ph.D
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heon-Ju Lee, MD, Ph.D
Phone
+82-53-623-8001
Email
hjlee@ymu.ac.kr
First Name & Middle Initial & Last Name & Degree
Heon-Ju Lee, MD, Ph.D
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byung-Ik Kim, MD, Ph.D
Phone
82-2-2001-2050
Email
bik.kim@samsung.com
First Name & Middle Initial & Last Name & Degree
Byung-Ik Kim, MD, Ph.D
Facility Name
Kyunghee university Medical Center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byung-Ho Kim, MD, Ph.D
Phone
+82-2-958-8114
Email
kimbh@khu.ac.kr
First Name & Middle Initial & Last Name & Degree
Byung-Ho Kim, MD, Ph.D
Facility Name
Hanyang University Hospital
City
Seoul
ZIP/Postal Code
133-791
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dae-Won Jun, MD, Ph.D
Phone
+82-2-2290-8338
Email
noshin@hanyang.ac.kr
First Name & Middle Initial & Last Name & Degree
Dae-Won Jun, MD, Ph.D
Facility Name
Kangdong Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
134-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyoung-Su Kim, MD, MS
Phone
+82-2224-2562
Email
hskim@hallym.or.kr
First Name & Middle Initial & Last Name & Degree
Hyoung-Su Kim, MD, MS
Facility Name
Kangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ja-Kyung Kim, MD, Ph.D
Phone
+82-2-2019-2330
Email
ceciliak@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Ja-Kyung Kim, MD, Ph.D
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
ZIP/Postal Code
139-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won-Choong Choi, MD, Ph.D
Phone
+82-2-950-1001
Email
wcc829@paik.ac.kr
First Name & Middle Initial & Last Name & Degree
Won-Choong Choi, MD, Ph.D
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
so young Kwon, MD, Ph.D
Phone
+82-2-2030-7070
Email
sykwonmd@hotmail.com
First Name & Middle Initial & Last Name & Degree
So-Young Kwon, MD, Ph.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
29998882
Citation
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.
Results Reference
derived

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

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