An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B

Hepatitis B, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730508
• Other study ID #: ML28516
• Status: Completed
• Phase: N/A
• First received: November 15, 2012
• Last updated: July 13, 2017
• Start date: November 20, 2012
• Est. completion date: June 25, 2017

Study information

• Verified date: July 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 978
• Est. completion date: June 25, 2017
• Est. primary completion date: June 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Pegylated Interferon Alfa (Peginterferon Alfa)
Peginterferon alfa dosing and treatment duration are at the discretion of the investigator in accordance with China clinical practice and local labeling.

Locations

Country	Name	City	State
China	The Fifth Hospital of Shijiazhuang	Baoding
China	Beijing 302 Hospital; No. 2 Infectious Disease Section	Beijing
China	Beijing Ditan Hospital	Beijing
China	Beijing Friendship Hospital	Beijing
China	Beijing Union Hospital	Beijing
China	Beijing You An Hospital; Digestive Dept	Beijing
China	Peking University Third Hospital	Beijing
China	Jilin Hepatobiliary Hospital	Changchun
China	the First Hospital of Jilin University	Changchun
China	Peoples Hospital of Hunan Province	Changsha
China	The Third Xiangya Hospital Of Central South University	Changsha
China	Changzhou 3rd People`s Hospital	Changzhou
China	West China Hospital, Sichuan University	Chengdu
China	Southwest Hospital , Third Military Medical University	Chongqing
China	The First Affiliated Hospital, Chongqing Medical University	Chongqing
China	The Second Affiliated Hospital, Chongqing Medical University	Chongqing
China	6th Hospital of Dalian City	Dalian
China	The First People's Hospital of Foshan	Foshan
China	The First People's Hospital of Shunde	Foushan
China	Fuzhou Infectious Diseases Hospital	Fuzhou
China	Guangdong Provincial Traditional Chinese Medicine Hospital	Guangzhou
China	Guangzhou First Municipal People's Hospital	Guangzhou
China	Nanfang Hospital, Southern Medical University	Guangzhou
China	The Eighth People's Hospital of Guangzhou	Guangzhou
China	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou
China	The First Affiliated Hospital of Jinan University	Guangzhou
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou
China	Guangdong General Hospital	Guangzhou City
China	Hainan provincial people's hospital	Haikou
China	The Affiliated Hospital of Hangzhou Normal University	Hangzhou
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 4th Affiliated Hospital of Harbin Medical University	Harbin
China	The First Affiliated Hospital of Anhui Medical University	Hefei
China	Huai'an No 4 People's Hospital	Huai'an
China	Jiangmen Wuyi Traditional Chinese Medicine Hospital	Jiangmen
China	Jiangyin People's Hospital	Jiangyin
China	Jinan Infectious Diseases Hospital	Jinan
China	Third people's Hospital of Kunming City	Kunming
China	The Second Gansu Province General Hospital	Lanzhou
China	The First People's Hospital of Lian Yun Gang	Lianyungang
China	Liuzhou Hospital of Traditional Chinese Medicine	Liuzhou
China	Affiliated Hospital of Luzhou medical college	LuZhou
China	The Ninth Hospital of Nanchang	Nanchang
China	Jiangsu Province Hospital	Nanjing
China	Nanjing No.2 Hospital; Liver Disease Department	Nanjing
China	The 81st Hospital of P.L.A.	Nanjing
China	Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine	Nanning
China	The First Affiliate Hospital of Guangxi Medical University	Nanning
China	Ningbo No.2 Hospital	Ningbo
China	Ordos No.2 Hospital	Ordos
China	QingDao Infection Diseases Hospital	Qingdao
China	Longhua Hospital, Shanghai University of Traditional Chinese Medicine	Shanghai
China	No.3 people's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai
China	Shanghai Huangpu District Central Hospital	Shanghai
China	Shanghai Public Health Clinical Center	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 First Hospital of Hebei Medical University	Shijiazhuang
China	Suining Central Hospital	Suining
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
China	Dagang Oil Field General Hospital	Tianjin
China	Tianjin Infectious Disease Hospital	Tianjin
China	The First Teaching Hospital of Xinjiang Medical University	Urumqi
China	Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine	Urumqi
China	Ruian People's Hospital	Wenzhou
China	The First Affiliated Hospital of Wenzhou Medical College	Wenzhou
China	Wenzhou Hospital of Traditional Chinese Medicine	Wenzhou
China	Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech	Wuhan
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	Xingtai People's Hospital	Xingtai
China	The Affiliated Hospital of Xuzhou Medical College	Xuzhou
China	Yancheng City No.1 People's Hospital	Yancheng
China	Yangzhou Third People's Hospital	Yangzhou
China	Central People's Hospital of Yichang	Yichang
China	Chinese medicine hospital of Zhaoqing City	Zhaoqing
China	Henan Provincial People's Hospital	Zhengzhou
China	Zhenjiang Third People's Hospital	Zhenjiang
China	Zhoushan Hospital	Zhoushan
China	Zhuhai People's Hospital	Zhuhai

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation		approximately 4 years
Secondary	Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment		approximately 4 years
Secondary	Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment		approximately 4 years
Secondary	Incidence of HBsAg loss/seroconversion		approximately 4 years
Secondary	Incidence of normalization of serum ALT levels		approximately 4 years
Secondary	Dosage/schedule of Pegasys treatment in real-life clinical setting		approximately 4 years
Secondary	Clinical/demographic patient characteristics at initiation of treatment		approximately 4 years
Secondary	Safety: Incidence of adverse events		approximately 4 years