An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B
- Conditions
- Hepatitis B, Chronic
- Interventions
- Drug: Pegylated Interferon Alfa (Peginterferon Alfa)
- Registration Number
- NCT01730508
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 978
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic Hepatitis B Participants Pegylated Interferon Alfa (Peginterferon Alfa) 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.
- Primary Outcome Measures
Name Time Method Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation approximately 4 years
- Secondary Outcome Measures
Name Time Method Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment approximately 4 years Incidence of normalization of serum ALT levels 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 Dosage/schedule of Pegasys treatment in real-life clinical setting approximately 4 years Clinical/demographic patient characteristics at initiation of treatment approximately 4 years Safety: Incidence of adverse events approximately 4 years
Trial Locations
- Locations (88)
The Second Gansu Province General Hospital
🇨🇳Lanzhou, China
Changzhou 3rd People's Hospital
🇨🇳Changzhou, China
The Eighth People's Hospital of Guangzhou
🇨🇳Guangzhou, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, China
Guangdong Provincial Traditional Chinese Medicine Hospital
🇨🇳Guangzhou, China
The Affiliated Hospital of Hangzhou Normal University
🇨🇳Hangzhou, China
Huai'an No 4 People's Hospital
🇨🇳Huai'an, China
The First People's Hospital of Foshan
🇨🇳Foshan, China
The First People's Hospital of Shunde
🇨🇳Foushan, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, China
The First Affiliated Hospital, Chongqing Medical University
🇨🇳Chongqing, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
🇨🇳Guangzhou, China
The First Affiliate Hospital of Guangxi Medical University
🇨🇳Nanning, China
No.3 people's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
The First Affiliated Hospital of Wenzhou Medical College
🇨🇳Wenzhou, China
Wenzhou Hospital of Traditional Chinese Medicine
🇨🇳Wenzhou, China
Yancheng City No.1 People's Hospital
🇨🇳Yancheng, China
Zhoushan Hospital
🇨🇳Zhoushan, China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
🇨🇳Wuhan, China
Jinan Infectious Diseases Hospital
🇨🇳Jinan, China
The Fifth Hospital of Shijiazhuang
🇨🇳Baoding, China
Beijing Ditan Hospital
🇨🇳Beijing, China
Beijing You An Hospital; Digestive Dept
🇨🇳Beijing, China
the First Hospital of Jilin University
🇨🇳Changchun, China
Peoples Hospital of Hunan Province
🇨🇳Changsha, China
The Second Affiliated Hospital, Chongqing Medical University
🇨🇳Chongqing, China
Guangdong General Hospital
🇨🇳Guangzhou City, China
Hainan provincial people's hospital
🇨🇳Haikou, China
The First Affiliated Hospital of College of Medicine, Zhejiang University(First Hospital of Zhejiang
🇨🇳Hangzhou, China
211 Military Hospital of China
🇨🇳Harbin, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, China
Jiangmen Wuyi Traditional Chinese Medicine Hospital
🇨🇳Jiangmen, China
Jiangyin People's Hospital
🇨🇳Jiangyin, China
Third people's Hospital of Kunming City
🇨🇳Kunming, China
Liuzhou Hospital of Traditional Chinese Medicine
🇨🇳Liuzhou, China
The First People's Hospital of Lian Yun Gang
🇨🇳Lianyungang, China
Affiliated Hospital of Luzhou medical college
🇨🇳LuZhou, China
Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
🇨🇳Nanning, China
Ningbo No.2 Hospital
🇨🇳Ningbo, China
Ordos No.2 Hospital
🇨🇳Ordos, China
QingDao Infection Diseases Hospital
🇨🇳Qingdao, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
The First Affiliated Hospital, Shantou University
🇨🇳Shantou, China
Shenzhen Donghu Hospital
🇨🇳Shen Zhen, China
Shengjing Hospital of China Medical University
🇨🇳ShenYang, China
Shenyang Sixth People's Hospital （Shenyang Infectious Disease Hospital）
🇨🇳Shenyang, China
Bethune International Peace Hospital of PLA
🇨🇳Shijiazhuang, China
The Fifth People's Hospital Suzhou; Infectious Disease
🇨🇳Suzhou, China
The Third Hospital of Taiyuan (Taiyuan Infectious Diseases Hospital)
🇨🇳Taiyuan, China
Tianjin Infectious Disease Hospital
🇨🇳Tianjin, China
Dagang Oil Field General Hospital
🇨🇳Tianjin, China
Suining Central Hospital
🇨🇳Suining, China
The First Teaching Hospital of Xinjiang Medical University
🇨🇳Urumqi, China
Ruian People's Hospital
🇨🇳Wenzhou, China
Wuxi No.5 People's Hospital
🇨🇳Wuxi, China
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
🇨🇳Xi'an, China
Xiamen Hospital of T.C.M
🇨🇳Xiamen, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, China
Zhenjiang Third People's Hospital
🇨🇳Zhenjiang, China
Zhuhai People's Hospital
🇨🇳Zhuhai, China
Xingtai People's Hospital
🇨🇳Xingtai, China
The Affiliated Hospital of Xuzhou Medical College
🇨🇳Xuzhou, China
Yangzhou Third People's Hospital
🇨🇳Yangzhou, China
Central People's Hospital of Yichang
🇨🇳Yichang, China
Chinese medicine hospital of Zhaoqing City
🇨🇳Zhaoqing, China
Beijing Union Hospital
🇨🇳Beijing, China
6th Hospital of Dalian City
🇨🇳Dalian, China
Beijing 302 Hospital; No. 2 Infectious Disease Section
🇨🇳Beijing, China
Beijing Friendship Hospital
🇨🇳Beijing, China
Jilin Hepatobiliary Hospital
🇨🇳Changchun, China
Peking University Third Hospital
🇨🇳Beijing, China
The Third Xiangya Hospital Of Central South University
🇨🇳Changsha, China
Southwest Hospital , Third Military Medical University
🇨🇳Chongqing, China
Fuzhou Infectious Diseases Hospital
🇨🇳Fuzhou, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Guangzhou First Municipal People's Hospital
🇨🇳Guangzhou, China
The 4th Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, China
The Ninth Hospital of Nanchang
🇨🇳Nanchang, China
Shanghai Public Health Clinical Center
🇨🇳Shanghai, China
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, China
Shanghai Huangpu District Central Hospital
🇨🇳Shanghai, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
🇨🇳Urumqi, China
Jiangsu Taizhou People's Hospital
🇨🇳Taizhou, China
Nanjing No.2 Hospital; Liver Disease Department
🇨🇳Nanjing, China
Jiangsu Province Hospital
🇨🇳Nanjing, China
The 81st Hospital of P.L.A.
🇨🇳Nanjing, China