A Study to Collect Blood Biomarker Samples From Participants With Chronic Hepatitis B (CHB) Who Received Treatment With Pegasys (Peginterferon Alfa-2a) ± Nucleoside/Nucleotide Analogue
NCT ID: NCT01855997
Last Updated: 2017-04-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1669 participants
OBSERVATIONAL
2013-08-20
2014-11-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)
NCT02604823
Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B
NCT01277601
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
NCT00962871
A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression
NCT01706575
A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
NCT02791269
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adult CHB Participants Treated With Peg-IFN Alfa-2a
Adult participants with CHB infection, and who have completed at least 24 weeks of Peg-IFN alfa-2a with/without nucleoside analogue therapy and at least 24 weeks of follow-up, will be included. Participants will be recruited from Roche clinical trials or general practice; no treatment will be administered in this non-interventional study.
Peg-IFN alfa-2a
Participants received Peg-IFN alfa-2a prior to enrollment for at least 24 weeks. Dosing was chosen according to standard of care or at the discretion of the treating physician.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peg-IFN alfa-2a
Participants received Peg-IFN alfa-2a prior to enrollment for at least 24 weeks. Dosing was chosen according to standard of care or at the discretion of the treating physician.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* CHB
* Previously enrolled in a Roche study and treated for CHB for ≥24 weeks with Peg-IFN ± nucleoside analogue (lamivudine or entecavir) or Peg-IFN ± nucleotide analogue (adefovir) and with ≥24 weeks post-treatment follow-up; or
* Treated in general practice for CHB with Peg-IFN according to standard of care and in line with the current Summary of Product Characteristics (SmPC)/local labeling who have no contraindication to Peg-IFN therapy as per local label and have been treated with Peg-IFN for ≥24 weeks and have ≥24 week post-treatment response available at the time of blood sample collection
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
Vienna, , Austria
MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
Sofia, , Bulgaria
Mhat Sveta Marina; Clinic of Gastroenterology
Varna, , Bulgaria
Beijing Ditan Hospital
Beijing, , China
Beijing 302 Hospital; No. 2 Infectious Disease Section
Beijing, , China
Peking University People's Hospital
Beijing, , China
Beijing You An Hospital; Digestive Dept
Beijing, , China
Xiangya Hospital of Centre-South University
Changsha, , China
West China Hospital, Sichuan University
Chengdu, , China
The Second Affiliated Hospital, Chongqing Medical University
Chongqing, , China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, , China
The Eighth People's Hospital of Guangzhou
Guangzhou, , China
Nanfang Hospital, Southern Medical University
Guangzhou, , China
Guangdong General Hospital
Guangzhou, , China
Hangzhou Sixth People's Hospital
Hangzhou, , China
The 1st Affiliated Hospital of Harbin Medical University
Harbin, , China
Jinan Infectious Diseases Hospital
Jinan, , China
Nanjing No.2 Hospital; Liver Disease Department
Nanjing, , China
The First Affiliate Hospital of Guangxi Medical University
Nanning, , China
Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, , China
Shanghai Public Health Clinical Center
Shanghai, , China
Shenzhen Donghu Hospital
Shenzhen, , China
The Third Hospital of Hebei Medical University
Shijiazhuang, , China
Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
Ürümqi, , China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, , China
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, , China
General Hospital of Ningxia Medical University
Yinchuan, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Hopital Beaujon;Hepatologie
Clichy, , France
Hopital Henri Mondor; Hepatologie Gastro Enterologie
Créteil, , France
Hopital de Pontchaillou; Medicine Interne - Hepatologie
Rennes, , France
Institut Arnault Tzanck; Medecine I Gastro Enterologie
Saint-Laurent-du-Var, , France
Praxis Dr. med. Christine John
Berlin, , Germany
Praxis Dr. Heyne
Berlin, , Germany
Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie
Berlin, , Germany
Ifi- Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
Hamburg, , Germany
Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie
Hanover, , Germany
Laiko General Hospital Athen; Uni Clinic of Gastrenterology
Athens, , Greece
University Hospital of Larissa; Pathological Clinic
Larissa, , Greece
Hippokratio Hospital; 4Th Internal Medicine Dpt
Thessaloniki, , Greece
Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive
Bari, Apulia, Italy
Ospedale de Bellis; Reparto Medicina Generale
Castellana Grotte, Apulia, Italy
Az. Osp. S. Sebastiano; Divisione Malattie Infettive
Caserta, Campania, Italy
Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia
Napoli, Campania, Italy
UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
Bologna, Emilia-Romagna, Italy
Az. Osp. Uni Ria Di Parma; Gastro-Enterology
Parma, Emilia-Romagna, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
Milan, Lombardy, Italy
Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale
Milan, Lombardy, Italy
Uni Di Cagliari; Dept. Di Scienze Mediche
Cagliari, Sardinia, Italy
Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia
Palermo, Sicily, Italy
Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
Pisa, Tuscany, Italy
Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.
Padua, Veneto, Italy
Auckland Hospital; New Zealand Liver Transplant Unit
Auckland, , New Zealand
Hospital For Infectious Diseases; Infectiology
Bydgoszcz, , Poland
Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny
Chorzów, , Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II; Oddzial Wirusowego Zapalenia Watroby
Krakow, , Poland
Specjalistyczny Szpital Wojewódzki im. Biegańskiego; Klinika Chorób Zakaźnych i Hepatologii UM
Lodz, , Poland
Wojewodzki Szpital Zakazny; Klinika Chorob Zakaznych
Warsaw, , Poland
Centralny Szpital Kliniczny MSWiA; Oddzial Chorob Wewnetrznych i Hepatologii
Warsaw, , Poland
NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby
Zielona Góra, , Poland
Centrum Medyczne
Łańcut, , Poland
Hospital de Santa Maria; Servico de Gastrenterologia e Hepatologia
Lisbon, , Portugal
Hospital Geral de Santo Antonio; Servico de Gastrenterologia
Porto, , Portugal
Hospital de Sao Joao; Servico de Gastrenterologia
Porto, , Portugal
Institutul De Boli Infectioase Matei Bals; Sectia Clinica II Boli Infectioase Adulti
Bucharest, , Romania
The Hospital of Tropical and Infectious Disease Victor Babes
Bucharest, , Romania
Clinical Infectious Diseases Hospital Victor Babes
Craiova, , Romania
Inje University Busan Paik Hospital; Nephrology
Busan, , South Korea
Chooncheon Sacred Heart Hospital
Chooncheon, , South Korea
Samsung Medical Center; Gastroenterology
Seoul, , South Korea
Changhua Christian Hospital; Internal Medicine
Changhua, , Taiwan
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
Kaohsiung City, , Taiwan
Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
Keelung, , Taiwan
China Medical University Hospital; Department of Rheumatology
Taichung, , Taiwan
National Taiwan Uni Hospital; Gastro-Enterology Dept.
Taipei, , Taiwan
Taipei Veterans General Hospital; Gastroenterology Division
Taipei, , Taiwan
Tri-Service Hospital; Dept. of Internal Medicine
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
Taoyuan District, , Taiwan
Siriraj Hospital
Bangkok, , Thailand
Chiang Mai Uni Hospital; Faculty of Medicine
Chiang Mai, , Thailand
Songklanagarind Hospital; Division of Gastroenterology
Songkhla, , Thailand
The Royal London Hospital
London, , United Kingdom
Manchester Royal Infirmary; Department Of Medicine
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wei L, Pavlovic V, Bansal AT, Chen X, Foster GR, He H, Kao JH, Lampertico P, Liaw YF, Motoc A, Papatheodoridis GV, Piratvisuth T, Plesniak R, Wat C. Genetic variation in FCER1A predicts peginterferon alfa-2a-induced hepatitis B surface antigen clearance in East Asian patients with chronic hepatitis B. J Viral Hepat. 2019 Sep;26(9):1040-1049. doi: 10.1111/jvh.13107. Epub 2019 Jul 23.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GV28855
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.