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

Information source: Hanyang University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B, Chronic

Intervention: Entecavir and Pegylated interferon α-2a Sequential Treatment Group (Drug); Pegylated interferon α-2a Monotreatment Group (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hanyang University

Official(s) and/or principal investigator(s):
Joo Hyun Sohn, MD, Ph.D, Principal Investigator, Affiliation: Hanyang University

Overall contact:
Joo Hyun Sohn, MD, Ph.D, Phone: +82-31-560-2225, Email: sonjh@hanyang.ac.kr

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

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: HBeAg seroconversion

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Joo Hyun Sohn, MD, Ph.D, Phone: +82-31-560-2225, Email: sonjh@hanyang.ac.kr

Dong-A University Medical Center, Busan 602-103, Korea, Republic of; Recruiting
Sungwook Lee, MD, Ph.D, Phone: +82-51-240-2400, Email: sunglee@dau.ac.kr
Sungwook Lee, MD, Ph.D, Principal Investigator

Inje University Haeundae Paik Hospital, Busan 612-030, Korea, Republic of; Recruiting
Seung-ha Park, MD, Ph.D, Phone: +82-51-797-0100, Email: obgyy@medimail.co.kr
Seung-Ha Park, MD, Ph.D, Principal Investigator

Kosin University Gospel Hospital, Busan 602-702, Korea, Republic of; Recruiting
Byung-cheol Yun, MD, Ph.D, Phone: +82-51-990-6114, Email: ybchepa@ns.kosinmed.or.kr
Byung-Cheol Yun, MD, Ph.D, Principal Investigator

Kyungpook National University Hospital, Daegu 700-721, Korea, Republic of; Recruiting
Won-young Tak, MD, Ph.D, Phone: +82-53-420-5114, Email: wytak@knu.ac.kr
Won-Young Tak, MD, Ph.D, Principal Investigator

Yeungnam University Medical Center, Daegu 705-717, Korea, Republic of; Recruiting
Heon-Ju Lee, MD, Ph.D, Phone: +82-53-623-8001, Email: hjlee@ymu.ac.kr
Heon-Ju Lee, MD, Ph.D, Principal Investigator

Hanyang University Hospital, Seoul 133-791, Korea, Republic of; Recruiting
Dae-Won Jun, MD, Ph.D, Phone: +82-2-2290-8338, Email: noshin@hanyang.ac.kr
Dae-Won Jun, MD, Ph.D, Principal Investigator

Inje University Sanggye Paik Hospital, Seoul 139-707, Korea, Republic of; Recruiting
Won-Choong Choi, MD, Ph.D, Phone: +82-2-950-1001, Email: wcc829@paik.ac.kr
Won-Choong Choi, MD, Ph.D, Principal Investigator

Kangbuk Samsung Hospital, Seoul 110-746, Korea, Republic of; Recruiting
Byung-Ik Kim, MD, Ph.D, Phone: 82-2-2001-2050, Email: bik.kim@samsung.com
Byung-Ik Kim, MD, Ph.D, Principal Investigator

Kangdong Sacred Heart Hospital, Seoul 134-701, Korea, Republic of; Recruiting
Hyoung-Su Kim, MD, MS, Phone: +82-2224-2562, Email: hskim@hallym.or.kr
Hyoung-Su Kim, MD, MS, Principal Investigator

Kangnam Severance Hospital, Seoul 135-720, Korea, Republic of; Recruiting
Ja-Kyung Kim, MD, Ph.D, Phone: +82-2-2019-2330, Email: ceciliak@yuhs.ac
Ja-Kyung Kim, MD, Ph.D, Principal Investigator

Konkuk University Medical Center, Seoul 143-729, Korea, Republic of; Recruiting
so young Kwon, MD, Ph.D, Phone: +82-2-2030-7070, Email: sykwonmd@hotmail.com
So-Young Kwon, MD, Ph.D, Principal Investigator

Kyunghee university Medical Center, Seoul 130-702, Korea, Republic of; Recruiting
Byung-Ho Kim, MD, Ph.D, Phone: +82-2-958-8114, Email: kimbh@khu.ac.kr
Byung-Ho Kim, MD, Ph.D, Principal Investigator

Dankook University Hospital, Cheonan, Chungcheongnam-do 330-715, Korea, Republic of; Recruiting
Il-Han Song, MD, Ph.D, Phone: +82-41-550-6694, Email: ihsong21@dankook.ac.kr
Il-Han Song, MD, Ph.D, Principal Investigator

Chuncheon Sacred Heart Hospital, Chuncheon, Gangwon-do 200-704, Korea, Republic of; Recruiting
Dong-Joon Kim, MD, Ph.D, Phone: +82-33-240-5646, Email: djkim@hallym.ac.kr
Dong-Joon Kim, MD, Ph.D, Principal Investigator

Wonju Christian Hospital, Wonju, Gangwon-do 220-701, Korea, Republic of; Recruiting
Soon Koo Baik, MD, Ph.D, Phone: +82-33-741-0114, Email: paiksk@yonsei.ac.kr
Soon Koo Baik, MD, Ph.D, Principal Investigator

Soon Chun Hyang University Bucheon Hospital, Bucheon, Gyeonggi-do 420-767, Korea, Republic of; Recruiting
Sang-gyune Kim, MD, MS, Phone: +82-32-621-5114, Email: mcnulty@schbc.ac.kr
Sang-Gyune Kim, MD, MS, Principal Investigator

Hanyang University Guri Hospital, Guri, Gyeonggi-do 471-854, Korea, Republic of; Recruiting
Joo Hyun Sohn, MD, Ph.D, Phone: +82-31-560-2225, Email: sonjh@hanyang.ac.kr
Joo Hyun Sohn, MD, Ph.D, Principal Investigator

Bundang CHA medical center, Sungnam, Gyeonggi-do 463-712, Korea, Republic of; Recruiting
Seong-Gyu Hwang, MD, Ph.D, Phone: +82-31-780-5000, Email: sghwang@cha.ac.kr
Seong-Gyu Hwang, MD, Ph.D, Principal Investigator

Busan National University Yangsan Hospital, Yangsan, Gyeongsangnam-do 626-770, Korea, Republic of; Recruiting
Ki-Tae Yoon, MD, MS, Phone: 82-55-360-1412, Email: ktyoon@pnuyh.co.kr
Ki-Tae Yoon, MD, MS, Principal Investigator

Jeju National University Hospital, Jeju, Jeju-do 690-767, Korea, Republic of; Recruiting
Byung-Cheol Song, MD, Ph.D, Phone: +82-64-717-1114, Email: drsong@cheju.ac.kr
Byung-Cheol Song, MD, Ph.D, Principal Investigator

Additional Information

Starting date: June 2010
Last updated: July 1, 2011

Page last updated: August 23, 2015

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