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

July 13, 2017 updated by: Hoffmann-La Roche

A MULTICENTER, PROSPECTIVE, OBSERVATIONAL, NON-INTERVENTIONAL COHORT STUDY IN CHINESE SUBJECTS WITH HBeAg NEGATIVE CHRONIC HEPATITIS B (CHB) RECEIVING THERAPY WITH PEGINTERFERON ALFA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

978

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Chinese participants with HBeAg negative chronic hepatitis B receiving treatment with Pegasys

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation
Time Frame: approximately 4 years
approximately 4 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2012

Primary Completion (Actual)

June 25, 2017

Study Completion (Actual)

June 25, 2017

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Actual)

July 14, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28516

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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