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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Peginterferon alfa-2a monotherapy | Active Comparator | Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir and Pegylated interferon α-2a Sequential Treatment Group | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HBeAg seroconversion | 24 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| the change of HBsAg titer | 24 weeks after treatment | |
| the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml | 24 weeks after treatment | |
| The rate of serum HBV DNA < 300 copies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joo Hyun Sohn, MD, Ph.D | Contact | +82-31-560-2225 | sonjh@hanyang.ac.kr | |
| Dae-Won Jun, MD, Ph.D | Contact | +82-2-2290-8338 | noshin@hanyang.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Joo Hyun Sohn, MD, Ph.D | Hanyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Medical Center | Recruiting | Busan | Busan | 602-103 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29998882 | Derived | 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. |
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|
| Pegylated interferon α-2a Monotreatment Group | Drug | Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks |
|
|
| 24 weeks after treatment |
| The rate of ALT normalization | 24 weeks after treatment |
| The rate of HBsAg loss | 24 weeks after treatment |
| Kosin University Gospel Hospital | Recruiting | Busan | Busan | 602-702 | South Korea |
|
| Inje University Haeundae Paik Hospital | Recruiting | Busan | Busan | 612-030 | South Korea |
|
| Dankook University Hospital | Recruiting | Cheonan | Chungcheongnam-do | 330-715 | South Korea |
|
| Kyungpook National University Hospital | Recruiting | Daegu | Daegu | 700-721 | South Korea |
|
| Yeungnam University Medical Center | Recruiting | Daegu | Daegu | 705-717 | South Korea |
|
| Chuncheon Sacred Heart Hospital | Recruiting | Chuncheon | Gangwon-do | 200-704 | South Korea |
|
| Wonju Christian Hospital | Recruiting | Wŏnju | Gangwon-do | 220-701 | South Korea |
|
| Soon Chun Hyang University Bucheon Hospital | Recruiting | Bucheon-si | Gyeonggi-do | 420-767 | South Korea |
|
| Hanyang University Guri Hospital | Recruiting | Guri-si | Gyeonggi-do | 471-854 | South Korea |
|
| Bundang CHA medical center | Recruiting | Sungnam | Gyeonggi-do | 463-712 | South Korea |
|
| Busan National University Yangsan Hospital | Recruiting | Yangsan | Gyeongsangnam-do | 626-770 | South Korea |
|
| Jeju National University Hospital | Recruiting | Jeju City | Jeju-do | 690-767 | South Korea |
|
| Kangbuk Samsung Hospital | Recruiting | Seoul | Seoul | 110-746 | South Korea |
|
| Kyunghee university Medical Center | Recruiting | Seoul | Seoul | 130-702 | South Korea |
|
| Hanyang University Hospital | Recruiting | Seoul | Seoul | 133-791 | South Korea |
|
| Kangdong Sacred Heart Hospital | Recruiting | Seoul | Seoul | 134-701 | South Korea |
|
| Kangnam Severance Hospital | Recruiting | Seoul | Seoul | 135-720 | South Korea |
|
| Inje University Sanggye Paik Hospital | Recruiting | Seoul | Seoul | 139-707 | South Korea |
|
| Konkuk University Medical Center | Recruiting | Seoul | Seoul | 143-729 | South Korea |
|
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C413685 | entecavir |
| D016568 | Drugs, Generic |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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