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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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