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Hepatitis B, ChronicNCT01730508

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

An observational study of Hepatitis B, Chronic, run by Hoffmann-La Roche at 88 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
Pegylated Interferon Alfa (Peginterferon Alfa)
How many people
978 participants
Where
88 sitesChina
Study dates
20 Nov 2012to 25 Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Chinese participants with HBeAg negative chronic hepatitis B receiving treatment with Pegasys

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

88 sites in 1 country.

88 sites in 1 country

China88 sites

  • The Fifth Hospital of Shijiazhuang

    Baoding

  • Beijing Ditan Hospital

    Beijing, 100011

  • Beijing 302 Hospital; No. 2 Infectious Disease Section

    Beijing, 100039

  • Beijing Friendship Hospital

    Beijing, 100050

  • Beijing You An Hospital; Digestive Dept

    Beijing, 100069

  • Peking University Third Hospital

    Beijing, 100083

  • Beijing Union Hospital

    Beijing, 100730

  • the First Hospital of Jilin University

    Changchun, 130021

  • Jilin Hepatobiliary Hospital

    Changchun

  • Peoples Hospital of Hunan Province

    Changsha, 410007

  • The Third Xiangya Hospital Of Central South University

    Changsha, 410013

  • Changzhou 3rd People's Hospital

    Changzhou, 213001

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • The Second Affiliated Hospital, Chongqing Medical University

    Chongqing, 400010

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016

  • Southwest Hospital , Third Military Medical University

    Chongqing, 400038

  • 6th Hospital of Dalian City

    Dalian, 116031

  • The First People's Hospital of Foshan

    Foshan

  • The First People's Hospital of Shunde

    Foushan

  • Fuzhou Infectious Diseases Hospital

    Fuzhou, 350025

  • The Eighth People's Hospital of Guangzhou

    Guangzhou, 510060

  • Guangdong General Hospital

    Guangzhou, 510080

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, 510405

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515

  • The First Affiliated Hospital of Jinan University

    Guangzhou, 510630

  • Guangdong Provincial Traditional Chinese Medicine Hospital

    Guangzhou

  • Hainan provincial people's hospital

    Haikou, 570311

  • The First Affiliated Hospital of College of Medicine, Zhejiang University(First Hospital of Zhejiang

    Hangzhou, 310003

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou

  • 211 Military Hospital of China

    Harbin

  • The 4th Affiliated Hospital of Harbin Medical University

    Harbin

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Huai'an No 4 People's Hospital

    Huai'an, 223001

  • Jiangmen Wuyi Traditional Chinese Medicine Hospital

    Jiangmen, 529000

  • Jiangyin People's Hospital

    Jiangyin

  • Jinan Infectious Diseases Hospital

    Jinan, 250021

  • Third people's Hospital of Kunming City

    Kunming, 650041

  • The Second Gansu Province General Hospital

    Lanzhou

  • The First People's Hospital of Lian Yun Gang

    Lianyungang, 222002

  • Liuzhou Hospital of Traditional Chinese Medicine

    Liuzhou

  • Affiliated Hospital of Luzhou medical college

    Luzhou, 646000

  • The Ninth Hospital of Nanchang

    Nanchang, 330002

  • Nanjing No.2 Hospital; Liver Disease Department

    Nanjing, 210003

  • Jiangsu Province Hospital

    Nanjing, 210036

  • The 81st Hospital of P.L.A.

    Nanjing

  • Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine

    Nanning, 530011

  • The First Affiliate Hospital of Guangxi Medical University

    Nanning, 530021

  • Ningbo No.2 Hospital

    Ningbo

  • Ordos No.2 Hospital

    Ordos

  • QingDao Infection Diseases Hospital

    Qingdao, 266033

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, 200025

  • Shanghai Public Health Clinical Center

    Shanghai, 201508

  • No.3 people's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 201999

  • Longhua Hospital, Shanghai University of Traditional Chinese Medicine

    Shanghai

  • Shanghai Huangpu District Central Hospital

    Shanghai

  • The First Affiliated Hospital, Shantou University

    Shantou, 515041

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

  • Shenyang Sixth People's Hospital （Shenyang Infectious Disease Hospital）

    Shenyang

  • Shenzhen Donghu Hospital

    Shenzhen, 518020

  • The First Hospital of Hebei Medical University

    Shijiazhuang, 050031

  • Bethune International Peace Hospital of PLA

    Shijiazhuang, 050082

  • Suining Central Hospital

    Suining, 629000

  • The Fifth People's Hospital Suzhou; Infectious Disease

    Suzhou

  • The Third Hospital of Taiyuan (Taiyuan Infectious Diseases Hospital)

    Taiyuan

  • Jiangsu Taizhou People's Hospital

    Taizhou, 225300

  • Tianjin Infectious Disease Hospital

    Tianjin, 300192

  • Dagang Oil Field General Hospital

    Tianjin

  • Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine

    Ürümqi, 830001

  • The First Teaching Hospital of Xinjiang Medical University

    Ürümqi, 830054

  • The First Affiliated Hospital of Wenzhou Medical College

    Wenzhou, 325000

  • Wenzhou Hospital of Traditional Chinese Medicine

    Wenzhou, 325000

  • Ruian People's Hospital

    Wenzhou, 325200

  • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

    Wuhan, 430030

  • Wuxi No.5 People's Hospital

    Wuxi, 214005

  • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)

    Xi'an, 710038

  • Xiamen Hospital of T.C.M

    Xiamen

  • Xingtai People's Hospital

    Xingtai

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, 221004

  • Yancheng City No.1 People's Hospital

    Yancheng, 224005

  • Yangzhou Third People's Hospital

    Yangzhou, 225009

  • Central People's Hospital of Yichang

    Yichang

  • Chinese medicine hospital of Zhaoqing City

    Zhaoqing, 526020

  • Henan Provincial People's Hospital

    Zhengzhou, 450003

  • Zhenjiang Third People's Hospital

    Zhenjiang, 212005

  • Zhoushan Hospital

    Zhoushan, 316000

  • Zhuhai People's Hospital

    Zhuhai, 519099

Other trials in China

About this study

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

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.

Being tested
Pegylated Interferon Alfa (Peginterferon Alfa)
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pegylated Interferon Alfa (Peginterferon Alfa)Drug

    Also called Pegasys

    Peginterferon alfa dosing and treatment duration are at the discretion of the investigator in accordance with China clinical practice and local labeling.

Study groups in NCT01730508
Study groupRoleWhat they receive
Chronic Hepatitis B ParticipantsHepatitis 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.
Receives: Drug: Pegylated Interferon Alfa (Peginterferon Alfa)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation

    Measured: approximately 4 years

Secondary outcomes (7)

  1. Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment

    Measured: approximately 4 years

  2. Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment

    Measured: approximately 4 years

  3. Incidence of HBsAg loss/seroconversion

    Measured: approximately 4 years

  4. Incidence of normalization of serum ALT levels

    Measured: approximately 4 years

  5. Dosage/schedule of Pegasys treatment in real-life clinical setting

    Measured: approximately 4 years

  6. Clinical/demographic patient characteristics at initiation of treatment

    Measured: approximately 4 years

  7. Safety: Incidence of adverse events

    Measured: approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2012 (estimated)
  2. Study start20 Nov 2012
  3. Primary completion25 Jun 2017
  4. Study completion25 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
978 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01730508
Sponsor's protocol ID
ML28516
Status last verified
Jul 2017
First submitted
15 Nov 2012
Last updated
14 Jul 2017
Results posted
No

Publications

  • Chen X, Mao Q, Xie Y, Dou X, Xie Q, Sheng J, Gao Z, Zhou X, Liu Y, Zheng H, Zhang S, Li S, Zhu F, Xu Y, Zhang M, Hu Y, Chen X, Huang Y, Ren H, Jia J. A Potential Functional Cure in Chinese HBeAg-negative Chronic Hepatitis B Patients Treated with Peg-interferon Alpha-2a. J Clin Transl Hepatol. 2019 Sep 28;7(3):249-257. doi: 10.14218/JCTH.2019.00016. Epub 2019 Aug 20.

    PubMed 31608217

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis B, Chronic, run by Hoffmann-La Roche at 88 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation (time frame: approximately 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01730508, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.

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