CClinicalTrials.gg
Sign In
Status unknownNCT01220596POTENTUpdated Jul 4, 2011

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

A Phase 3 interventional study of Entecavir and Pegylated interferon α-2a Sequential Treatment Group and Pegylated interferon α-2a Monotreatment Group in Hepatitis B, Chronic, sponsored by Hanyang University. Status unknown at 20 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-04.

Sponsored by Hanyang University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
228
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Hepatitis B, Chronic
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 228 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Hanyang University is the lead sponsor of 51 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
228 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugEntecavir 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

    Also known as: Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM), Generic/Brand name: Entecavir/Baraclude(TM)

  • DrugPegylated interferon α-2a Monotreatment Group

    Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks

    Also known as: Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM)

06

What researchers measure

Primary outcomes

  1. HBeAg seroconversion

    Time frame: 24 weeks after treatment

Secondary outcomes

  1. the change of HBsAg titer

    Time frame: 24 weeks after treatment

  2. the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml

    Time frame: 24 weeks after treatment

  3. The rate of serum HBV DNA < 300 copies

    Time frame: 24 weeks after treatment

  4. The rate of ALT normalization

    Time frame: 24 weeks after treatment

  5. The rate of HBsAg loss

    Time frame: 24 weeks after treatment

07

Study locations

20 of 20 sites recruiting
  • Dankook University Hospital
    Cheonan, Chungcheongnam-do 330-715, Korea, Republic of
    • Il-Han Song, MD, Ph.D · Contact · ihsong21@dankook.ac.kr · +82-41-550-6694
    • Il-Han Song, MD, Ph.D · Principal investigator
    Recruiting
  • Chuncheon Sacred Heart Hospital
    Chuncheon, Gangwon-do 200-704, Korea, Republic of
    • Dong-Joon Kim, MD, Ph.D · Contact · djkim@hallym.ac.kr · +82-33-240-5646
    • Dong-Joon Kim, MD, Ph.D · Principal investigator
    Recruiting
  • Wonju Christian Hospital
    Wonju, Gangwon-do 220-701, Korea, Republic of
    • Soon Koo Baik, MD, Ph.D · Contact · paiksk@yonsei.ac.kr · +82-33-741-0114
    • Soon Koo Baik, MD, Ph.D · Principal investigator
    Recruiting
  • Soon Chun Hyang University Bucheon Hospital
    Bucheon, Gyeonggi-do 420-767, Korea, Republic of
    • Sang-gyune Kim, MD, MS · Contact · mcnulty@schbc.ac.kr · +82-32-621-5114
    • Sang-Gyune Kim, MD, MS · Principal investigator
    Recruiting
  • Hanyang University Guri Hospital
    Guri, Gyeonggi-do 471-854, Korea, Republic of
    • Joo Hyun Sohn, MD, Ph.D · Contact · sonjh@hanyang.ac.kr · +82-31-560-2225
    • Joo Hyun Sohn, MD, Ph.D · Principal investigator
    Recruiting
  • Bundang CHA medical center
    Sungnam, Gyeonggi-do 463-712, Korea, Republic of
    • Seong-Gyu Hwang, MD, Ph.D · Contact · sghwang@cha.ac.kr · +82-31-780-5000
    • Seong-Gyu Hwang, MD, Ph.D · Principal investigator
    Recruiting
  • Busan National University Yangsan Hospital
    Yangsan, Gyeongsangnam-do 626-770, Korea, Republic of
    • Ki-Tae Yoon, MD, MS · Contact · ktyoon@pnuyh.co.kr · 82-55-360-1412
    • Ki-Tae Yoon, MD, MS · Principal investigator
    Recruiting
  • Jeju National University Hospital
    Jeju, Jeju-do 690-767, Korea, Republic of
    • Byung-Cheol Song, MD, Ph.D · Contact · drsong@cheju.ac.kr · +82-64-717-1114
    • Byung-Cheol Song, MD, Ph.D · Principal investigator
    Recruiting
  • Dong-A University Medical Center
    Busan, 602-103, Korea, Republic of
    • Sungwook Lee, MD, Ph.D · Contact · sunglee@dau.ac.kr · +82-51-240-2400
    • Sungwook Lee, MD, Ph.D · Principal investigator
    Recruiting
  • Kosin University Gospel Hospital
    Busan, 602-702, Korea, Republic of
    • Byung-cheol Yun, MD, Ph.D · Contact · ybchepa@ns.kosinmed.or.kr · +82-51-990-6114
    • Byung-Cheol Yun, MD, Ph.D · Principal investigator
    Recruiting
  • Inje University Haeundae Paik Hospital
    Busan, 612-030, Korea, Republic of
    • Seung-ha Park, MD, Ph.D · Contact · obgyy@medimail.co.kr · +82-51-797-0100
    • Seung-Ha Park, MD, Ph.D · Principal investigator
    Recruiting
  • Kyungpook National University Hospital
    Daegu, 700-721, Korea, Republic of
    • Won-young Tak, MD, Ph.D · Contact · wytak@knu.ac.kr · +82-53-420-5114
    • Won-Young Tak, MD, Ph.D · Principal investigator
    Recruiting
  • Yeungnam University Medical Center
    Daegu, 705-717, Korea, Republic of
    • Heon-Ju Lee, MD, Ph.D · Contact · hjlee@ymu.ac.kr · +82-53-623-8001
    • Heon-Ju Lee, MD, Ph.D · Principal investigator
    Recruiting
  • Kangbuk Samsung Hospital
    Seoul, 110-746, Korea, Republic of
    • Byung-Ik Kim, MD, Ph.D · Contact · bik.kim@samsung.com · 82-2-2001-2050
    • Byung-Ik Kim, MD, Ph.D · Principal investigator
    Recruiting
  • Kyunghee university Medical Center
    Seoul, 130-702, Korea, Republic of
    • Byung-Ho Kim, MD, Ph.D · Contact · kimbh@khu.ac.kr · +82-2-958-8114
    • Byung-Ho Kim, MD, Ph.D · Principal investigator
    Recruiting
  • Hanyang University Hospital
    Seoul, 133-791, Korea, Republic of
    • Dae-Won Jun, MD, Ph.D · Contact · noshin@hanyang.ac.kr · +82-2-2290-8338
    • Dae-Won Jun, MD, Ph.D · Principal investigator
    Recruiting
  • Kangdong Sacred Heart Hospital
    Seoul, 134-701, Korea, Republic of
    • Hyoung-Su Kim, MD, MS · Contact · hskim@hallym.or.kr · +82-2224-2562
    • Hyoung-Su Kim, MD, MS · Principal investigator
    Recruiting
  • Kangnam Severance Hospital
    Seoul, 135-720, Korea, Republic of
    • Ja-Kyung Kim, MD, Ph.D · Contact · ceciliak@yuhs.ac · +82-2-2019-2330
    • Ja-Kyung Kim, MD, Ph.D · Principal investigator
    Recruiting
  • Inje University Sanggye Paik Hospital
    Seoul, 139-707, Korea, Republic of
    • Won-Choong Choi, MD, Ph.D · Contact · wcc829@paik.ac.kr · +82-2-950-1001
    • Won-Choong Choi, MD, Ph.D · Principal investigator
    Recruiting
  • Konkuk University Medical Center
    Seoul, 143-729, Korea, Republic of
    • so young Kwon, MD, Ph.D · Contact · sykwonmd@hotmail.com · +82-2-2030-7070
    • So-Young Kwon, MD, Ph.D · Principal investigator
    Recruiting
08

References and documents

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. PubMed 29998882 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01220596
Lead sponsor
Hanyang University
Collaborators
Roche Pharma AG
First posted
Oct 14, 2010
Start date
Jun 2010
Primary completion
Jun 2013 (estimated)
Completion
Jun 2013 (estimated)
Last update
Jul 4, 2011

Study contacts

Joo Hyun Sohn, MD, Ph.D
Contact
sonjh@hanyang.ac.kr
+82-31-560-2225
Dae-Won Jun, MD, Ph.D
Contact
noshin@hanyang.ac.kr
+82-2-2290-8338
Joo Hyun Sohn, MD, Ph.D
principal investigator · Hanyang University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatitis A→

Other studies from this sponsor

Hanyang University

Start the discussion