Clinical trial NCT01730508: An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B
Official title: A MULTICENTER, PROSPECTIVE, OBSERVATIONAL, NON-INTERVENTIONAL COHORT STUDY IN CHINESE SUBJECTS WITH HBeAg NEGATIVE CHRONIC HEPATITIS B (CHB) RECEIVING THERAPY WITH PEGINTERFERON ALFA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 978
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese participants with HBeAg negative chronic hepatitis B receiving treatment with Pegasys

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation
timeFrame: approximately 4 years
Secondary outcomes:
measure: Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment
timeFrame: approximately 4 years
measure: Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment
timeFrame: approximately 4 years
measure: Incidence of HBsAg loss/seroconversion
timeFrame: approximately 4 years
measure: Incidence of normalization of serum ALT levels
timeFrame: approximately 4 years
measure: Dosage/schedule of Pegasys treatment in real-life clinical setting
timeFrame: approximately 4 years
measure: Clinical/demographic patient characteristics at initiation of treatment
timeFrame: approximately 4 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 4 years
Other outcomes:
Locations:
city: Baoding
country: China
facility: The Fifth Hospital of Shijiazhuang
city: Beijing
country: China
facility: Beijing Ditan Hospital
city: Beijing
country: China
facility: Beijing 302 Hospital; No. 2 Infectious Disease Section
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Beijing You An Hospital; Digestive Dept
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Union Hospital
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Changchun
country: China
facility: Jilin Hepatobiliary Hospital
city: Changsha
country: China
facility: Peoples Hospital of Hunan Province
city: Changsha
country: China
facility: The Third Xiangya Hospital Of Central South University
city: Changzhou
country: China
facility: Changzhou 3rd People's Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: The Second Affiliated Hospital, Chongqing Medical University
city: Chongqing
country: China
facility: The First Affiliated Hospital, Chongqing Medical University
city: Chongqing
country: China
facility: Southwest Hospital , Third Military Medical University
city: Dalian
country: China
facility: 6th Hospital of Dalian City
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Foushan
country: China
facility: The First People's Hospital of Shunde
city: Fuzhou
country: China
facility: Fuzhou Infectious Diseases Hospital
city: Guangzhou City
country: China
facility: Guangdong General Hospital
city: Guangzhou
country: China
facility: The Eighth People's Hospital of Guangzhou
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
city: Guangzhou
country: China
facility: Guangdong Provincial Traditional Chinese Medicine Hospital
city: Haikou
country: China
facility: Hainan provincial people's hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University(First Hospital of Zhejiang
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University
city: Harbin
country: China
facility: 211 Military Hospital of China
city: Harbin
country: China
facility: The 4th Affiliated Hospital of Harbin Medical University
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Huai'an
country: China
facility: Huai'an No 4 People's Hospital
city: Jiangmen
country: China
facility: Jiangmen Wuyi Traditional Chinese Medicine Hospital
city: Jiangyin
country: China
facility: Jiangyin People's Hospital
city: Jinan
country: China
facility: Jinan Infectious Diseases Hospital
city: Kunming
country: China
facility: Third people's Hospital of Kunming City
city: Lanzhou
country: China
facility: The Second Gansu Province General Hospital
city: Lianyungang
country: China
facility: The First People's Hospital of Lian Yun Gang
city: Liuzhou
country: China
facility: Liuzhou Hospital of Traditional Chinese Medicine
city: LuZhou
country: China
facility: Affiliated Hospital of Luzhou medical college
city: Nanchang
country: China
facility: The Ninth Hospital of Nanchang
city: Nanjing
country: China
facility: Nanjing No.2 Hospital; Liver Disease Department
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: The 81st Hospital of P.L.A.
city: Nanning
country: China
facility: Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
city: Nanning
country: China
facility: The First Affiliate Hospital of Guangxi Medical University
city: Ningbo
country: China
facility: Ningbo No.2 Hospital
city: Ordos
country: China
facility: Ordos No.2 Hospital
city: Qingdao
country: China
facility: QingDao Infection Diseases Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
city: Shanghai
country: China
facility: No.3 people's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of Traditional Chinese Medicine
city: Shanghai
country: China
facility: Shanghai Huangpu District Central Hospital
city: Shantou
country: China
facility: The First Affiliated Hospital, Shantou University
city: Shen Zhen
country: China
facility: Shenzhen Donghu Hospital
city: ShenYang
country: China
facility: Shengjing Hospital of China Medical University
city: Shenyang
country: China
facility: Shenyang Sixth People's Hospital （Shenyang Infectious Disease Hospital）
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
city: Shijiazhuang
country: China
facility: Bethune International Peace Hospital of PLA
city: Suining
country: China
facility: Suining Central Hospital
city: Suzhou
country: China
facility: The Fifth People's Hospital Suzhou; Infectious Disease
city: Taiyuan
country: China
facility: The Third Hospital of Taiyuan (Taiyuan Infectious Diseases Hospital)
city: Taizhou
country: China
facility: Jiangsu Taizhou People's Hospital
city: Tianjin
country: China
facility: Tianjin Infectious Disease Hospital
city: Tianjin
country: China
facility: Dagang Oil Field General Hospital
city: Urumqi
country: China
facility: Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
city: Urumqi
country: China
facility: The First Teaching Hospital of Xinjiang Medical University
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical College
city: Wenzhou
country: China
facility: Wenzhou Hospital of Traditional Chinese Medicine
city: Wenzhou
country: China
facility: Ruian People's Hospital
city: Wuhan
country: China
facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
city: Wuxi
country: China
facility: Wuxi No.5 People's Hospital
city: Xi'an
country: China
facility: The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
city: Xiamen
country: China
facility: Xiamen Hospital of T.C.M
city: Xingtai
country: China
facility: Xingtai People's Hospital
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
city: Yancheng
country: China
facility: Yancheng City No.1 People's Hospital
city: Yangzhou
country: China
facility: Yangzhou Third People's Hospital
city: Yichang
country: China
facility: Central People's Hospital of Yichang
city: Zhaoqing
country: China
facility: Chinese medicine hospital of Zhaoqing City
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Zhenjiang
country: China
facility: Zhenjiang Third People's Hospital
city: Zhoushan
country: China
facility: Zhoushan Hospital
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.