An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B
A MULTICENTER, PROSPECTIVE, OBSERVATIONAL, NON-INTERVENTIONAL COHORT STUDY IN CHINESE SUBJECTS WITH HBeAg NEGATIVE CHRONIC HEPATITIS B (CHB) RECEIVING THERAPY WITH PEGINTERFERON ALFA
1 other identifier
observational
978
1 country
88
Brief Summary
This multicenter, prospective, observational study will evaluate the use in clinical practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with HBeAg negative chronic hepatitis B. Participants receiving Pegasys according to the local label will be followed for the duration of their treatment and for one year after cessation of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
Longer than P75 for all trials
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2012
CompletedStudy Start
First participant enrolled
November 20, 2012
CompletedFirst Posted
Study publicly available on registry
November 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2017
CompletedJuly 14, 2017
July 1, 2017
4.6 years
November 15, 2012
July 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation
approximately 4 years
Secondary Outcomes (7)
Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment
approximately 4 years
Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment
approximately 4 years
Incidence of HBsAg loss/seroconversion
approximately 4 years
Incidence of normalization of serum ALT levels
approximately 4 years
Dosage/schedule of Pegasys treatment in real-life clinical setting
approximately 4 years
- +2 more secondary outcomes
Study Arms (1)
Chronic Hepatitis B Participants
Hepatitis B e antigen (HBeAg) chronic hepatitis B (CHB) participants who received treatment with pegylated interferon alfa (peginterferon alfa) according to China labeling and China standard of care and were followed up to 1 year after treatment cessation.
Interventions
Peginterferon alfa dosing and treatment duration are at the discretion of the investigator in accordance with China clinical practice and local labeling.
Eligibility Criteria
Chinese participants with HBeAg negative chronic hepatitis B receiving treatment with Pegasys
You may qualify if:
- Adult participants, \>/= 18 years of age
- Treatment with Pegasys according to label and standard clinical practice
- HBeAg negative serologically proven chronic hepatitis B with or without cirrhosis
- Serum alanine aminotransferase (ALT) \> upper limit of normal (ULN) but \</= 10 x ULN
- Hepatitis B Virus (HBV) DNA \>/= 2000 IU/mL
You may not qualify if:
- Contraindications to Pegasys as detailed in the label
- Co-infection with hepatitis A, hepatitis C or HIV
- Pregnant or lactating women
- Participants should not receive concomitant therapy with telbivudine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (88)
The Fifth Hospital of Shijiazhuang
Baoding, China
Beijing Ditan Hospital
Beijing, 100011, China
Beijing 302 Hospital; No. 2 Infectious Disease Section
Beijing, 100039, China
Beijing Friendship Hospital
Beijing, 100050, China
Beijing You An Hospital; Digestive Dept
Beijing, 100069, China
Peking University Third Hospital
Beijing, 100083, China
Beijing Union Hospital
Beijing, 100730, China
the First Hospital of Jilin University
Changchun, 130021, China
Jilin Hepatobiliary Hospital
Changchun, China
Peoples Hospital of Hunan Province
Changsha, 410007, China
The Third Xiangya Hospital Of Central South University
Changsha, 410013, China
Changzhou 3rd People's Hospital
Changzhou, 213001, China
West China Hospital, Sichuan University
Chengdu, 610041, China
The Second Affiliated Hospital, Chongqing Medical University
Chongqing, 400010, China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, 400016, China
Southwest Hospital , Third Military Medical University
Chongqing, 400038, China
6th Hospital of Dalian City
Dalian, 116031, China
The First People's Hospital of Foshan
Foshan, China
The First People's Hospital of Shunde
Foushan, China
Fuzhou Infectious Diseases Hospital
Fuzhou, 350025, China
The Eighth People's Hospital of Guangzhou
Guangzhou, 510060, China
Guangdong General Hospital
Guangzhou, 510080, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, 510080, China
Guangzhou First Municipal People's Hospital
Guangzhou, 510180, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, 510405, China
Nanfang Hospital, Southern Medical University
Guangzhou, 510515, China
The First Affiliated Hospital of Jinan University
Guangzhou, 510630, China
Guangdong Provincial Traditional Chinese Medicine Hospital
Guangzhou, China
Hainan provincial people's hospital
Haikou, 570311, China
The First Affiliated Hospital of College of Medicine, Zhejiang University(First Hospital of Zhejiang
Hangzhou, 310003, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, China
211 Military Hospital of China
Harbin, China
The 4th Affiliated Hospital of Harbin Medical University
Harbin, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
Huai'an No 4 People's Hospital
Huai'an, 223001, China
Jiangmen Wuyi Traditional Chinese Medicine Hospital
Jiangmen, 529000, China
Jiangyin People's Hospital
Jiangyin, China
Jinan Infectious Diseases Hospital
Jinan, 250021, China
Third people's Hospital of Kunming City
Kunming, 650041, China
The Second Gansu Province General Hospital
Lanzhou, China
The First People's Hospital of Lian Yun Gang
Lianyungang, 222002, China
Liuzhou Hospital of Traditional Chinese Medicine
Liuchow, China
Affiliated Hospital of Luzhou medical college
Luzhou, 646000, China
The Ninth Hospital of Nanchang
Nanchang, 330002, China
Nanjing No.2 Hospital; Liver Disease Department
Nanjing, 210003, China
Jiangsu Province Hospital
Nanjing, 210036, China
The 81st Hospital of P.L.A.
Nanjing, China
Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
Nanning, 530011, China
The First Affiliate Hospital of Guangxi Medical University
Nanning, 530021, China
Ningbo No.2 Hospital
Ningbo, China
Ordos No.2 Hospital
Ordos, China
QingDao Infection Diseases Hospital
Qingdao, 266033, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025, China
Shanghai Public Health Clinical Center
Shanghai, 201508, China
No.3 people's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 201999, China
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, China
Shanghai Huangpu District Central Hospital
Shanghai, China
The First Affiliated Hospital, Shantou University
Shantou, 515041, China
Shengjing Hospital of China Medical University
Shenyang, 110004, China
Shenyang Sixth People's Hospital （Shenyang Infectious Disease Hospital）
Shenyang, China
Shenzhen Donghu Hospital
Shenzhen, 518020, China
The First Hospital of Hebei Medical University
Shijiazhuang, 050031, China
Bethune International Peace Hospital of PLA
Shijiazhuang, 050082, China
Suining Central Hospital
Suining, 629000, China
The Fifth People's Hospital Suzhou; Infectious Disease
Suzhou, China
The Third Hospital of Taiyuan (Taiyuan Infectious Diseases Hospital)
Taiyuan, China
Jiangsu Taizhou People's Hospital
Taizhou, 225300, China
Tianjin Infectious Disease Hospital
Tianjin, 300192, China
Dagang Oil Field General Hospital
Tianjin, China
Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
Ürümqi, 830001, China
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, 830054, China
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, 325000, China
Wenzhou Hospital of Traditional Chinese Medicine
Wenzhou, 325000, China
Ruian People's Hospital
Wenzhou, 325200, China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, 430030, China
Wuxi No.5 People's Hospital
Wuxi, 214005, China
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, 710038, China
Xiamen Hospital of T.C.M
Xiamen, China
Xingtai People's Hospital
Xingtai, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221004, China
Yancheng City No.1 People's Hospital
Yancheng, 224005, China
Yangzhou Third People's Hospital
Yangzhou, 225009, China
Central People's Hospital of Yichang
Yichang, China
Chinese medicine hospital of Zhaoqing City
Zhaoqing, 526020, China
Henan Provincial People's Hospital
Zhengzhou, 450003, China
Zhenjiang Third People's Hospital
Zhenjiang, 212005, China
Zhoushan Hospital
Zhoushan, 316000, China
Zhuhai People's Hospital
Zhuhai, 519099, China
Related Publications (1)
Chen X, Mao Q, Xie Y, Dou X, Xie Q, Sheng J, Gao Z, Zhou X, Liu Y, Zheng H, Zhang S, Li S, Zhu F, Xu Y, Zhang M, Hu Y, Chen X, Huang Y, Ren H, Jia J. A Potential Functional Cure in Chinese HBeAg-negative Chronic Hepatitis B Patients Treated with Peg-interferon Alpha-2a. J Clin Transl Hepatol. 2019 Sep 28;7(3):249-257. doi: 10.14218/JCTH.2019.00016. Epub 2019 Aug 20.
PMID: 31608217DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2012
First Posted
November 21, 2012
Study Start
November 20, 2012
Primary Completion
June 25, 2017
Study Completion
June 25, 2017
Last Updated
July 14, 2017
Record last verified: 2017-07