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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01730508
First received: November 15, 2012
Last updated: July 13, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention
Hepatitis B, Chronic Drug: Pegylated Interferon Alfa (Peginterferon Alfa)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation [ Time Frame: approximately 4 years ]

Secondary Outcome Measures:
  • Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment [ Time Frame: approximately 4 years ]
  • Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment [ Time Frame: approximately 4 years ]
  • Incidence of HBsAg loss/seroconversion [ Time Frame: approximately 4 years ]
  • Incidence of normalization of serum ALT levels [ Time Frame: approximately 4 years ]
  • Dosage/schedule of Pegasys treatment in real-life clinical setting [ Time Frame: approximately 4 years ]
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: approximately 4 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ]

Enrollment: 978
Actual Study Start Date: November 20, 2012
Study Completion Date: June 25, 2017
Primary Completion Date: June 25, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.
Other Name: Pegasys

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chinese participants with HBeAg negative chronic hepatitis B receiving treatment with Pegasys
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730508

  Hide Study Locations
Locations
China
The Fifth Hospital of Shijiazhuang
Baoding, China
Beijing Ditan Hospital
Beijing, China, 100011
Beijing 302 Hospital; No. 2 Infectious Disease Section
Beijing, China, 100039
Beijing Friendship Hospital
Beijing, China, 100050
Beijing You An Hospital; Digestive Dept
Beijing, China, 100069
Peking University Third Hospital
Beijing, China, 100083
Beijing Union Hospital
Beijing, China, 100730
the First Hospital of Jilin University
Changchun, China, 130021
Jilin Hepatobiliary Hospital
Changchun, China
Peoples Hospital of Hunan Province
Changsha, China, 410007
The Third Xiangya Hospital Of Central South University
Changsha, China, 410013
Changzhou 3rd People`s Hospital
Changzhou, China, 213001
West China Hospital, Sichuan University
Chengdu, China, 610041
The Second Affiliated Hospital, Chongqing Medical University
Chongqing, China, 400010
The First Affiliated Hospital, Chongqing Medical University
Chongqing, China, 400016
Southwest Hospital , Third Military Medical University
Chongqing, China, 400038
6th Hospital of Dalian City
Dalian, China, 116031
The First People's Hospital of Foshan
Foshan, China
The First People's Hospital of Shunde
Foushan, China
Fuzhou Infectious Diseases Hospital
Fuzhou, China, 350025
Guangdong General Hospital
Guangzhou City, China, 510080
The Eighth People's Hospital of Guangzhou
Guangzhou, China, 510060
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China, 510080
Guangzhou First Municipal People's Hospital
Guangzhou, China, 510180
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, China, 510405
Nanfang Hospital, Southern Medical University
Guangzhou, China, 510515
The First Affiliated Hospital of Jinan University
Guangzhou, China, 510630
Guangdong Provincial Traditional Chinese Medicine Hospital
Guangzhou, China
Hainan provincial people's hospital
Haikou, China, 570311
The First Affiliated Hospital of College of Medicine, Zhejiang University(First Hospital of Zhejiang
Hangzhou, China, 310003
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, China, 230022
Huai'an No 4 People's Hospital
Huai'an, China, 223001
Jiangmen Wuyi Traditional Chinese Medicine Hospital
Jiangmen, China, 529000
Jiangyin People's Hospital
Jiangyin, China
Jinan Infectious Diseases Hospital
Jinan, China, 250021
Third people's Hospital of Kunming City
Kunming, China, 650041
The Second Gansu Province General Hospital
Lanzhou, China
The First People's Hospital of Lian Yun Gang
Lianyungang, China, 222002
Liuzhou Hospital of Traditional Chinese Medicine
Liuzhou, China
Affiliated Hospital of Luzhou medical college
LuZhou, China, 646000
The Ninth Hospital of Nanchang
Nanchang, China, 330002
Nanjing No.2 Hospital; Liver Disease Department
Nanjing, China, 210003
Jiangsu Province Hospital
Nanjing, China, 210036
The 81st Hospital of P.L.A.
Nanjing, China
Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
Nanning, China, 530011
The First Affiliate Hospital of Guangxi Medical University
Nanning, China, 530021
Ningbo No.2 Hospital
Ningbo, China
Ordos No.2 Hospital
Ordos, China
QingDao Infection Diseases Hospital
Qingdao, China, 266033
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025
Shanghai Public Health Clinical Center
Shanghai, China, 201508
No.3 people's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 201999
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, China
Shanghai Huangpu District Central Hospital
Shanghai, China
The First Affiliated Hospital, Shantou University
Shantou, China, 515041
Shenzhen Donghu Hospital
Shen Zhen, China, 518020
Shengjing Hospital of China Medical University
ShenYang, China, 110004
Shenyang Sixth People's Hospital (Shenyang Infectious Disease Hospital)
Shenyang, China
The First Hospital of Hebei Medical University
Shijiazhuang, China, 050031
Bethune International Peace Hospital of PLA
Shijiazhuang, China, 050082
Suining Central Hospital
Suining, China, 629000
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, 225300
Tianjin Infectious Disease Hospital
Tianjin, China, 300192
Dagang Oil Field General Hospital
Tianjin, China
Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
Urumqi, China, 830001
The First Teaching Hospital of Xinjiang Medical University
Urumqi, China, 830054
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, China, 325000
Wenzhou Hospital of Traditional Chinese Medicine
Wenzhou, China, 325000
Ruian People's Hospital
Wenzhou, China, 325200
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, China, 430030
Wuxi No.5 People's Hospital
Wuxi, China, 214005
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, China, 710038
Xiamen Hospital of T.C.M
Xiamen, China
Xingtai People's Hospital
Xingtai, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, China, 221004
Yancheng City No.1 People's Hospital
Yancheng, China, 224005
Yangzhou Third People's Hospital
Yangzhou, China, 225009
Central People's Hospital of Yichang
Yichang, China
Chinese medicine hospital of Zhaoqing City
Zhaoqing, China, 526020
Henan Provincial People's Hospital
Zhengzhou, China, 450003
Zhenjiang Third People's Hospital
Zhenjiang, China, 212005
Zhoushan Hospital
Zhoushan, China, 316000
Zhuhai People's Hospital
Zhuhai, China, 519099
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01730508     History of Changes
Other Study ID Numbers: ML28516
Study First Received: November 15, 2012
Last Updated: July 13, 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017