Hepatitis B, ChronicPhase 3POTENTNCT01220596
Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B.
A Phase 3 study testing Entecavir and Pegylated interferon α-2a Sequential Treatment Group and Pegylated interferon α-2a Monotreatment Group in people with Hepatitis B, Chronic, run by Hanyang University at 20 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Entecavir and Pegylated interferon α-2a Sequential Treatment Group and Pegylated interferon α-2a Monotreatment Group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 20 sitesSouth Korea
- Study dates
- Jun 2010to Jun 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient infected concurrently with HCV, HDV and HIV or patient with a history of antiviral treatment for Hepatitis B or patient with hepatic decompensation.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
South Korea20 sites, 20 recruiting
- Recruiting
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 420-767
Sang-gyune Kim, MD, MS, +82-32-621-5114, mcnulty@schbc.ac.kr
Sang-Gyune Kim, MD, MS
- Recruiting
Dong-A University Medical Center
Busan, Busan, 602-103
Sungwook Lee, MD, Ph.D, +82-51-240-2400, sunglee@dau.ac.kr
Sungwook Lee, MD, Ph.D
- Recruiting
Kosin University Gospel Hospital
Busan, Busan, 602-702
Byung-cheol Yun, MD, Ph.D, +82-51-990-6114, ybchepa@ns.kosinmed.or.kr
Byung-Cheol Yun, MD, Ph.D
- Recruiting
Inje University Haeundae Paik Hospital
Busan, Busan, 612-030
Seung-ha Park, MD, Ph.D, +82-51-797-0100, obgyy@medimail.co.kr
Seung-Ha Park, MD, Ph.D
- Recruiting
Dankook University Hospital
Cheonan, Chungcheongnam-do, 330-715
Il-Han Song, MD, Ph.D, +82-41-550-6694, ihsong21@dankook.ac.kr
Il-Han Song, MD, Ph.D
- Recruiting
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 200-704
Dong-Joon Kim, MD, Ph.D, +82-33-240-5646, djkim@hallym.ac.kr
Dong-Joon Kim, MD, Ph.D
- Recruiting
Kyungpook National University Hospital
Daegu, Daegu, 700-721
Won-young Tak, MD, Ph.D, +82-53-420-5114, wytak@knu.ac.kr
Won-Young Tak, MD, Ph.D
- Recruiting
Yeungnam University Medical Center
Daegu, Daegu, 705-717
Heon-Ju Lee, MD, Ph.D, +82-53-623-8001, hjlee@ymu.ac.kr
Heon-Ju Lee, MD, Ph.D
- Recruiting
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 471-854
Joo Hyun Sohn, MD, Ph.D, +82-31-560-2225, sonjh@hanyang.ac.kr
Joo Hyun Sohn, MD, Ph.D
- Recruiting
Jeju National University Hospital
Jeju City, Jeju-do, 690-767
Byung-Cheol Song, MD, Ph.D, +82-64-717-1114, drsong@cheju.ac.kr
Byung-Cheol Song, MD, Ph.D
- Recruiting
Kangbuk Samsung Hospital
Seoul, Seoul, 110-746
Byung-Ik Kim, MD, Ph.D, 82-2-2001-2050, bik.kim@samsung.com
Byung-Ik Kim, MD, Ph.D
- Recruiting
Kyunghee university Medical Center
Seoul, Seoul, 130-702
Byung-Ho Kim, MD, Ph.D, +82-2-958-8114, kimbh@khu.ac.kr
Byung-Ho Kim, MD, Ph.D
- Recruiting
Hanyang University Hospital
Seoul, Seoul, 133-791
Dae-Won Jun, MD, Ph.D, +82-2-2290-8338, noshin@hanyang.ac.kr
Dae-Won Jun, MD, Ph.D
- Recruiting
Kangdong Sacred Heart Hospital
Seoul, Seoul, 134-701
Hyoung-Su Kim, MD, MS, +82-2224-2562, hskim@hallym.or.kr
Hyoung-Su Kim, MD, MS
- Recruiting
Kangnam Severance Hospital
Seoul, Seoul, 135-720
Ja-Kyung Kim, MD, Ph.D, +82-2-2019-2330, ceciliak@yuhs.ac
Ja-Kyung Kim, MD, Ph.D
- Recruiting
Inje University Sanggye Paik Hospital
Seoul, Seoul, 139-707
Won-Choong Choi, MD, Ph.D, +82-2-950-1001, wcc829@paik.ac.kr
Won-Choong Choi, MD, Ph.D
- Recruiting
Konkuk University Medical Center
Seoul, Seoul, 143-729
so young Kwon, MD, Ph.D, +82-2-2030-7070, sykwonmd@hotmail.com
So-Young Kwon, MD, Ph.D
- Recruiting
Bundang CHA medical center
Sungnam, Gyeonggi-do, 463-712
Seong-Gyu Hwang, MD, Ph.D, +82-31-780-5000, sghwang@cha.ac.kr
Seong-Gyu Hwang, MD, Ph.D
- Recruiting
Wonju Christian Hospital
Wŏnju, Gangwon-do, 220-701
Soon Koo Baik, MD, Ph.D, +82-33-741-0114, paiksk@yonsei.ac.kr
Soon Koo Baik, MD, Ph.D
- Recruiting
Busan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 626-770
Ki-Tae Yoon, MD, MS, 82-55-360-1412, ktyoon@pnuyh.co.kr
Ki-Tae Yoon, MD, MS
About this study
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.
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
- Conditions
- Hepatitis B, Chronic
- Being tested
- Entecavir and Pegylated interferon α-2a Sequential Treatment Group, Pegylated interferon α-2a Monotreatment Group
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavir and Pegylated interferon α-2a Sequential Treatment GroupDrug
Also called Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM), Generic/Brand name: Entecavir/Baraclude(TM)
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 Monotreatment GroupDrug
Also called Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM)
Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sequential therapy | Experimental | 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 Receives: Drug: Entecavir and Pegylated interferon α-2a Sequential Treatment Group |
| Peginterferon alfa-2a monotherapy | Active comparator | Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks Receives: Drug: Pegylated interferon α-2a Monotreatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBeAg seroconversion
Measured: 24 weeks after treatment
Secondary outcomes (5)
the change of HBsAg titer
Measured: 24 weeks after treatment
the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml
Measured: 24 weeks after treatment
The rate of serum HBV DNA < 300 copies
Measured: 24 weeks after treatment
The rate of ALT normalization
Measured: 24 weeks after treatment
The rate of HBsAg loss
Measured: 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Joo Hyun Sohn, MD, Ph.D, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220596
- Sponsor's protocol ID
- ML25206
- Acronym
- POTENT
- Status last verified
- Jun 2011
- First submitted
- 13 Oct 2010
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01220596
- Acronym / sponsor ID
- POTENT / ML25206
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jun 2010
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 14 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential therapy | Experimental | Drug: Entecavir and Pegylated interferon α-2a Sequential Treatment GroupEntecavir/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 |
| Peginterferon alfa-2a monotherapy | Active comparator | Drug: Pegylated interferon α-2a Monotreatment GroupPegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient infected concurrently with HCV, HDV and HIV or patient with a history of antiviral treatment for Hepatitis B or patient with hepatic decompensation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entecavir and Pegylated interferon α-2a Sequential Treatment GroupAlso: Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM), Generic/Brand name: Entecavir/Baraclude(TM)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 | Sequential therapy |
| Pegylated interferon α-2a Monotreatment GroupAlso: Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM)Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks | Drug | Peginterferon alfa-2a monotherapy |
Primary outcome
HBeAg seroconversion
Time frame: 24 weeks after treatment
5 secondary outcomes
the change of HBsAg titer
Time frame: 24 weeks after treatment
the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml
Time frame: 24 weeks after treatment
The rate of serum HBV DNA < 300 copies
Time frame: 24 weeks after treatment
The rate of ALT normalization
Time frame: 24 weeks after treatment
The rate of HBsAg loss
Time frame: 24 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2011.
- Derived from this study: PubMed 29998882Jun 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.
Related trials for Hepatitis B, Chronic
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo Hyun Sohn, MD, Ph.D principal investigator
Hanyang University
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Entecavir and Pegylated interferon α-2a Sequential Treatment Group and Pegylated interferon α-2a Monotreatment Group in people with Hepatitis B, Chronic, run by Hanyang University at 20 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joo Hyun Sohn, MD, Ph.D (+82-31-560-2225, sonjh@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBeAg seroconversion (time frame: 24 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01220596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2011.