An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys

A Multicenter, Prospective, Observational, Non-Interventional Cohort Study Evaluating On-Treatment Predictors of Response in Subjects With HBeAg Positive and HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS(R) (Peginterferon Alfa-2a 40KD)

This observational, non-interventional cohort study will evaluate predictors of response in patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and safety parameters will also be evaluated. Patients included in the study will be followed for the duration of their treatment and for up to 3 years thereafter.

Study Overview

• Status: Completed
• Conditions: Hepatitis B, Chronic

• Study Type: Observational
• Enrollment (Actual): 1842

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • LKH-Univ. Klinikum Graz
  • Innsbruck, Austria, 6020
    • Tiroler Landeskrankenanstalten Ges.M.B.H.; Klinische Abt. Für Gaströnterologie & Hepatologie
  • Linz, Austria, 4010
    • A.Ö. Krankenhaus Der Elisabethinen Linz; Iv. Med. Abtl.
  • Wien, Austria, 1090
    • Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
  • Wien, Austria, 1160
    • Wilhelminenspital; Iv. Medizinische Abt.
• Bahrain
  • Manama, Bahrain, 12
    • Salmaniya Medical Complex; Gastroenterology
• Bangladesh
  • Dhaka, Bangladesh, 1205
    • Liver Clinic Lab-Aid Specialized Hospital
  • Dhaka, Bangladesh, 1209
    • The Liver Centre
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • Clinical Center Banja Luka; Department for Infective Diseases
  • Bihac, Bosnia and Herzegovina, 77000
    • Cantonal Hospital Bihac; Department for Infective Diseses
  • Mostar, Bosnia and Herzegovina, 88000
    • Clinical Hospital Mostar; Department for Gastroenterology
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Clinical Center Sarajevo; Gastroenterohepatology
  • Tuzla, Bosnia and Herzegovina, 75000
    • University Clinical Center Tuzla; Clinic for Gastroenterology
  • Tuzla, Bosnia and Herzegovina, 75000
    • University Clinical Center Tuzla; Clinic for Infective Diseases
  • Zenica, Bosnia and Herzegovina, 72000
    • Cantonal Hospital Zenica; Department for Infective Diseases
• Bulgaria
  • Sofia, Bulgaria, 1407
    • MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
  • Varna, Bulgaria, 9010
    • Mhat Sveta Marina; Clinic of Gastroenterology
• China
  • Beijing, China, 100044
    • Peking University People's 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
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Chongqing, China, 400010
    • The Second Affiliated Hospital, Chongqing Medical University
  • Guangzhou, China
    • Guangdong General Hospital
  • Guangzhou, China, 510060
    • The Eighth People's Hospital of Guangzhou
  • Hangzhou, China
    • Hangzhou Sixth People's Hospital
  • Harbin, China, 150001
    • The 1st Affiliated Hospital of Harbin Medical University
  • Jinan, China, 250021
    • JiNan Infectious Diseases Hospital
  • Nanjing, China, 210003
    • Nanjing No.2 Hospital; Liver Disease Department
  • Shanghai, China, 200040
    • Huashan Hospital Affiliated to Fudan University
  • Shanghai, China, 200025
    • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai, China, 201508
    • Shanghai Public Health Clinical Center
  • Shanghai, China, 200235
    • The 85th Hospital of P.L.A.
  • Shen Zhen, China, 518020
    • Shenzhen Donghu Hospital
  • ShenYang, China, 110004
    • Shengjing Hospital of China Medical University
  • Shi Jiazhuang, China, 050051
    • The Third Hospital of Hebei Medical University
  • Shijiazhuang, China, 050082
    • Bethune International Peace Hospital of PLA
  • Urumqi, China, 830001
    • Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
  • Wenzhou, China, 325000
    • The First Affiliated Hospital of Wenzhou Medical College
  • Xi'an, China, 710038
    • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
• Egypt
  • Cairo, Egypt
    • Dr. Ibrahim Mostafa Clinic
  • Cairo, Egypt
    • Yehia Elshazly Clinic for Hepatology and Gastroentrology
  • Cairo, Egypt
    • Dr.Mohamed Amr Affifi Clinic
  • Cairo, Egypt
    • Dr.Nabil Fawzy private clinic
  • Cairo, Egypt
    • Dr.Nadia Elansary Clinic
  • Giza, Egypt
    • Dr. Taher Elzanaty clinic
  • Giza, Egypt
    • Dr. Ahmed Monis Clinic
  • Mansoura, Egypt
    • Gamal Sheha Clinic
• France
  • Aix En Provence, France, 13616
    • Ch Du Pays D Aix; Gastro Enterologie
  • Amiens, France, 80054
    • Hopital Nord; Medecine A
  • Amiens, France, 80054
    • Hopital Nord; Reseau Hepatologie Picardie
  • Angers, France, 49033
    • Hotel Dieu; Medecine A
  • Argenteuil, France, 95107
    • Ch Victor Dupouy; Hepato Gastro Medecine Interne
  • Argenteuil, France, 95107
    • Ch Victor Dupouy; Oncologie
  • Avignon, France, 84902
    • Ch Henri Duffaut;Gastro Enterologie
  • Besancon, France, 25030
    • Hopital Jean Minjoz; Hepatologie
  • Bobigny, France, 93009
    • Hopital Avicenne; Unite D Hepatologie
  • Bondy, France, 93143
    • Hopital Jean Verdier; Gastro Enterologie
  • Bordeaux, France, 33000
    • Hopital Saint Andre; Hepato-Gastro-Enterologie
  • Bourgoin Jallieu, France, 38317
    • Ch Pierre Oudot; Gastro Enterologie
  • Caen, France, 14033
    • Hopital Cote De Nacre; Gastro Enterologie
  • Chambray Les Tours, France, 37171
    • Hopital Trousseau; Gastro Enterologie A Et B
  • Clamart, France, 92141
    • Hopital Antoine Beclere; Hepatologie Gastro Enterologie
  • Clermont Ferrand, France, 63003
    • Chu Estaing; Medecine Digestive
  • Clichy, France, 92118
    • Hopital Beaujon; Gastro Enterologie 1
  • Clichy, France, 92118
    • Hopital Beaujon;Hepatologie
  • Corbeil Essonnes, France, 91106
    • Ch Sud Francilien; Cons Gastro Enterologie
  • Creil, France, 60109
    • Ch Laennec; Medecine IV
  • Creteil, France, 94010
    • Hopital Henri Mondor; Hepatologie Gastro Enterologie
  • Dijon, France, 21079
    • Hopital Du Bocage; Gastro Enterologie
  • Evry, France, 91014
    • Ch Sud Francilien; Gastro Enterologie
  • Grasse, France, 06130
    • Cabinet
  • La Tronche, France, 38700
    • Hopital Albert Michallon; Gastro Enterologie
  • Lagny Sur Marne, France, 77405
    • Ch De Lagny Sur Marne; Gastro Enterologie
  • Le Kremlin Bicetre, France, 94275
    • Ch De Bicetre; Gastro Enterologie
  • Le Mans, France, 72037
    • Ch Du Mans; Medecine Ii
  • Lille, France, 59037
    • Hopital Claude Huriez;Gastro Enterologie
  • Limoges, France, 87042
    • Hopital Dupuytren; Medecine Interne A
  • Lyon, France, 69317
    • Hopital De La Croix Rousse; Hepatologie Gastro Enterologie
  • Lyon, France, 69009
    • Clinique De La Sauvegarde; Exploration Gastro Proctologie
  • Lyon, France, 69288
    • Hopital Hotel Dieu; Medecine Interne & D'Hepatologie
  • Marseille, France, 13285
    • Fondation Hopital Saint Joseph; Gastro-Enterologie
  • Marseille, France, 13385
    • Hopital De La Conception; Gastro Enterologie Endoscopie 2E Nord
  • Marseille, France, 13385
    • Hopital De La Conception; Rhumatologie
  • Metz, France, 57038
    • Hopital N D Bon Secours; Medecine B2
  • Montauban, France, 82013
    • Ch De Montauban; Medecine Interne
  • Montivilliers, France, 76290
    • Hopital Jacques Monod; Gastro-Enterologie
  • Montpellier, France, 34295
    • Hopital Saint-Eloi; Hepatologie-Gastro-Enterologie
  • Montpellier, France, 34070
    • Cabinet Medical
  • Mulhouse, France, 68070
    • Hopital Emile Muller; Gastro Enterologie
  • Nantes, France, 44093
    • Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie
  • Nantes, France, 44200
    • Cabinet
  • Nimes, France, 30029
    • Hopital Caremeau; Gastro Enterologie
  • Niort, France, 79021
    • Ch Georges Renon; Maladies Infectieuses
  • Orleans, France, 45100
    • Hopital La Source; Medecine H
  • Paris, France, 75571
    • Hopital Saint Antoine; Hepatologie-Gastr-Enterologie
  • Paris, France, 75877
    • Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie
  • Paris, France, 75006
    • Fondation Institut Arthur Vernes; Institut Arthur Vernes
  • Paris, France, 75651
    • CH Pitie Salpetriere; Hepathologie Gastro Enterologie
  • Perpignan, France, 66046
    • Hopital Saint Jean; Hematologie
  • Pessac, France, 33604
    • Hopital Du Haut-Leveque; Gastro-Enterologie
  • Reims, France, 51092
    • Hopital Robert Debre; Gastro Enterologie
  • Rennes, France, 35033
    • Hopital de Pontchaillou; Medicine Interne - Hepatologie
  • Rouen, France, 76031
    • Hopital Charles Nicolle; Gastro Enterologie
  • Saint Laurent Du Var, France, 06721
    • Institut Arnault Tzanck; Medecine I Gastro Enterologie
  • St Maurice, France, 94413
    • Hopital Esquirol; Cons Externes
  • Strasbourg, France, 67091
    • Hopital Civil; Hepatologie-Gastro-Enterologie
  • Toulon, France, 83000
    • Cabinet Medical Gastro Enterologie
  • Toulon, France, 83056
    • Hopital Font Pre; Gastro Enterologie
  • Toulouse, France, 31059
    • Hopital Purpan;Gastro Enterologie Hepatologie
  • Toulouse, France, 31082
    • Clinique Ambroise Pare; Medecine
  • Vandoeuvre-les-nancy, France, 54511
    • Hopitaux de Brabois - Gastro-Entereologie
  • Villejuif, France, 94804
    • Hopital Paul Brousse; Centre Hepatologie Biliaire
• Germany
  • Berlin, Germany, 13353
    • Campus Virchow-Klinikum Charité Centrum 13; Medizinische Klinik; Abt.Hepatologie u.Gastroenterologie
  • Berlin, Germany, 13353
    • CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie
  • Berlin, Germany, 12203
    • Charité - Campus Benjamin Franklin; Zentrum fuer Innere Medizin, Med. Klinik I
  • Berlin, Germany, 10117
    • Charité Universitätsmedizin Berlin; Campus Mitte, Centrum 12, Medizinische Poliklinik
  • Berlin, Germany, 10117
    • Praxis Dr. med. Christine John
  • Berlin, Germany, 10439
    • überörtl.Gem.Praxis Dres. Stephan Dupke Axel Baumgarten
  • Berlin, Germany, 10969
    • Dres.Bernd Möller und Renate Heyne
  • Berlin, Germany, 10969
    • Praxis Dr. Heyne
  • Berlin, Germany, 14057
    • Dres. Jörg Gölz und Arend Moll
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn Med. Klinik u. Poliklinik I
  • Düsseldorf, Germany, 40225
    • Universitätsklinikum Klinik f. Gastroenterologie Hepatologie und Infektiologie
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen; Medizinische Klinik 1
  • Essen, Germany, 45122
    • Universitaetsklinikum Essen, Innere Klinik und Poliklinik fuer Tumorforschung
  • Frankfurt am Main, Germany, 60594
    • Praxis PD Dr.med. Gerlinde Teuber
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg Medizinische Klinik Innere Medizin I
  • Giessen, Germany, 35392
    • Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik II
  • Hamburg, Germany, 20099
    • Med. Versorgungszentrum ifi-Institut
  • Hamburg, Germany, 20146
    • Infektionsmedizinisches Centrum Hamburg ICH Grindel
  • Hamm, Germany, 59071
    • St.Marien-Hospital Klinik Knappenstraße Klinik f.Gastroenterologie
  • Hannover, Germany, 30625
    • Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie
  • Heidelberg, Germany, 69120
    • Uni Heidelberg Med. Klinik; Innere Medizin IV
  • Herne, Germany, 44623
    • Dres.Dietrich Hüppe Gisela Felten und Heinz Hartmann
  • Jena, Germany, 07747
    • Universitätsklinikum Jena; Klinik für Innere Medizin II
  • Kiel, Germany, 24105
    • Universitätsklinikum S.-H. Campus Kiel Klinik für Innere Medizin I Gastroenterologie Hepotologie
  • Lübeck, Germany, 23562
    • Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Transplantationszentrum
  • Magdeburg, Germany, 39120
    • Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie
  • Mainz, Germany, 55131
    • Uniklinik Mainz; I. Medizinische Klinik
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU München; II. Medizinische Klinik & Poliklinik
  • Münster, Germany, 48143
    • Dr.med.Heiner W.Busch und Stefan Christensen
  • Münster, Germany, 48149
    • Universitätsklinikum Münster Klinik und Poliklinik für Transplantationsmedizin
  • Nürnberg, Germany, 90419
    • Klinikum Nord Medizinische Klinik 6
  • Offenburg, Germany, 77654
    • St. Josefs Klinik; Medizinische Klinik
  • Salzgitter, Germany, 38226
    • Klinikum Salzgitter-Lebenstedt Medizinische Klinik I
  • Stuttgart, Germany, 70197
    • Dres. Andreas Schaffert Andreas Trein und Edith Ißler u.w.
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
  • Wuerzburg, Germany, 97080
    • Medizinische Universitätsklinik; Med. Klinik Ii, Infektiologie
  • Wuppertal, Germany, 42277
    • Praxis Sabine Mauruschat
• Hong Kong
  • Tuen Mun, Hong Kong
    • Tuen Mun Hospital; Medicine & Geriatrics
• India
  • Gurgaon, India
    • Medanta -The Medicity; Department of Digestive and Hepatobiliary Sciences
  • Guwahati, India, 781005
    • Institute of Digestive Diseases
  • Mumbai, India, 400036
    • Opp Jaslok Hospital
  • Pune, India, 411004
    • Krishnai Clinic
  • Pune, India, 411004
    • Medipoint Clinic
  • Pune, India, 411005
    • Pai Clinic and Diagnostic Center
  • Trivandrum, India, 695 001
    • Sree Gokulam Medical College and Research Foundation
  • Delhi
    • New Delhi, Delhi, India, 110076
      • Indraprastha Apollo Hospitals
• Indonesia
  • Bandung, Indonesia, 40132
    • Boromeus Hospital; Hepatology
  • Bandung, Indonesia, 40181
    • Santosa Bandung International Hospital; Hepatology
  • Bandung, Indonesia
    • Hasan Sadikin Hospital; Digestive Surgery
  • Jakarta, Indonesia, 10430
    • Cipto Mangunkusumo General Hospital; Hematology & Oncology
  • Jakarta, Indonesia, 10150
    • Klinik Hati; Hepatology
  • Jakarta, Indonesia, 10330
    • PGI Cikini Hospital; Hepatology
  • Jakarta, Indonesia, 10410
    • Central Army Hospital Rspad Gatot Soebroto; Pulmonology
  • Jakarta, Indonesia, 12950
    • Medistra Hospital; Hepatology
  • Jakarta, Indonesia, 13310
    • Mitra International Jatinegara Hospital; Hepatology
  • Jakarta, Indonesia, 13430
    • Klinik Kimia Farma
  • Surabaya, Indonesia, 60286
    • Dr. Soetomo Hospital; Kidney and Hipertansion
  • Tangerang, Indonesia, 15224
    • Bintaro International Hospital, Hepatology
• Ireland
  • Dublin, Ireland, 7
    • Mater Misericordiae University Hospital;Gastrointestinal Unit/Center for Liver Disease
  • Dublin, Ireland, 8
    • St. James Hospital; Hepatology
• Jordan
  • Amman, Jordan, 1005
    • Al-Bashir Hospital
  • Amman, Jordan, 86 / 11118
    • Prince Hamzeh Hospital; Internal Medicine
  • Irbid, Jordan, 360001
    • King Abdullah University Hospital
• Korea, Republic of
  • Anyang, Korea, Republic of, 431-070
    • Pyungchon Sacred Heart Hospital
  • Busan, Korea, Republic of, 602-739
    • Pusan University Hospital
  • Busan, Korea, Republic of, 614-735
    • Inje University Pusan Paik Hospital
  • Chooncheon, Korea, Republic of, 200-060
    • Chooncheon Sacred Heart Hospital
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National Uni Hospital; Internal Medicine
  • Daejeon, Korea, Republic of, 301-846
    • Chungnam University Hospital
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital
  • Jeollabuk-do, Korea, Republic of, 561-712
    • Chonbuk National Uni Hospital
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Centre; Division of Hematology/Oncology
  • Seoul, Korea, Republic of, 01830
    • Eulji General Hospital
  • Seoul, Korea, Republic of, 06973
    • Chungang University Hospital
  • Seoul, Korea, Republic of, 120-752
    • Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept.
  • Seoul, Korea, Republic of
    • Korea Kuro Hospital; Internal Medicine
  • Seoungnamsi, Korea, Republic of, 463-824
    • Pundang Jesaeng General Hospital
  • Ulsan, Korea, Republic of, 44033
    • Ulsan University Hosiptal
• Lebanon
  • Beirut, Lebanon, 11-236
    • American University of Beirut - Medical Center
  • Beirut, Lebanon, 99999
    • Beirut Governmental University Hospital
  • Beirut, Lebanon, 99999
    • Hotel-Dieu de France Hospital; Gastroenterology
• Macedonia, The Former Yugoslav Republic of
  • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
    • Clinical Center Skopje; Gastroenterohepatology
  • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
    • Clinical Center Skopje; Infectious Diseases
• Morocco
  • Casablanca, Morocco, 20100
    • Cabinet Privé Pr D Jamil
  • Fes, Morocco, 30003
    • CHU Hassan 2; Service Gastro Enterologie Pr IBRAHIMI
  • Rabat, Morocco, 504
    • Centre Hospitalier Universitaire Ibn Sina; Service de Gastro-entérologie Essaid
• New Zealand
  • Auckland, New Zealand, 100
    • Auckland Hospital; New Zealand Liver Transplant Unit
  • Hamilton, New Zealand
    • Waikato Hospital; Gastroenterology
  • Whakatane, New Zealand
    • Hepatitis Foundation
• Pakistan
  • Faisalabad, Pakistan
    • Allied Hospital; Department of Medicine
  • Islamabad, Pakistan
    • Islamabad Specialist Clinic
  • Karachi, Pakistan
    • Akbar Center
  • Karachi, Pakistan
    • Dow University of Health Sciences; Department of Medicine
  • Karachi, Pakistan
    • Medicare Clinics
  • Lahore, Pakistan, 20021
    • Sheikh Zayed Hospital; Department of Gastroentrology
  • Lahore, Pakistan, 54500
    • Kanaan Clinic
  • Peshawar, Pakistan
    • Saeed Anwar Medical Centre
  • Rawalpindi, Pakistan
    • Combined Military Hospital; Department of Medicine
  • Rawalpindi, Pakistan
    • Holy Family Hospital; Department of Medicine
• Poland
  • Bialystok, Poland, 15-540
    • Medical Uni of Bialystok; Infectious Diseases
  • Bydgoszcz, Poland, 85-030
    • Hospital For Infectious Diseases; Infectiology
  • Chorzow, Poland, 41-500
    • Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny
  • Gdansk, Poland, 80-214
    • Pomorskie Centrum Chorob Zakaznych i Gruzlicy
  • Krakow, Poland, 31-202
    • Krakowski Szpital Specjalistyczny im. Jana Pawla II; Oddzial Wirusowego Zapalenia Watroby
  • Lancut, Poland, 37-100
    • Centrum Medyczne
  • Lodz, Poland, 91-347
    • Medical Uni of Lodz; Infectious Diseases
  • Lodz, Poland, 91-347
    • Wojewódzki specjalistyczny szpital im. Bieganskiego; Oddział Obserwacyjno-Zakazny i Chorob Watroby
  • Warszawa, Poland, 01-201
    • Inst. of Infectious & Parasitic Diseases; Clinic of Hepatology & Aquired Immunodeficiencies
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny MSWiA; Oddzial Chorob Wewnetrznych i Hepatologii
  • Wroclaw, Poland, 51-124
    • Wojewodzki Szpital; Specjalistyczny Chorob Zakaznych
  • Zielona Góra, Poland, 65-044
    • NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby
  • Łodz, Poland, 91-347
    • Specjalistyczny Szpital Wojewódzki im. Biegańskiego; Klinika Chorób Zakaźnych i Hepatologii UM
• Portugal
  • Lisboa, Portugal, 1649-035
    • Hospital de Santa Maria; Servico de Gastrenterologia e Hepatologia
  • Porto, Portugal, 4099-001
    • Hospital Geral de Santo Antonio; Servico de Gastrenterologia
  • Porto, Portugal, 4202-451
    • Hospital de Sao Joao; Servico de Gastrenterologia
• Romania
  • Bucharest, Romania, 020475
    • Cantacuzino Clinical Hospital;Gastroenterology Department
  • Bucharest, Romania, 021105
    • Institutul De Boli Infectioase Matei Bals; Sectia Clinica II Boli Infectioase Adulti
  • Bucharest, Romania, 030303
    • The Hospital of Tropical and Infectious Disease Victor Babes
  • Craiova, Romania, 200515
    • Clinical Infectious Diseases Hospital Victor Babes
  • Craiova, Romania, 200515
    • Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor; INFECTIOUS DISEASE
• Saudi Arabia
  • Alkhobar, Saudi Arabia, 31952
    • King Fahad University Hospital; Internal Medicine
  • Riyadh, Saudi Arabia, 11211
    • King Faisal Specialist Hospital & Research Centre; Oncology
  • Riyadh, Saudi Arabia, 11159
    • Riyadh Military Hospital
  • Riyadh, Saudi Arabia, 11525
    • King Fahad Medical City; Gastroentrology
  • Tabuk, Saudi Arabia, 71411
    • North West Armed Forces Hospital; Internal Medicine
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Chiang Mai, Thailand, 50200
    • Chiang Mai Uni Hospital; Faculty of Medicine
  • Songkhla, Thailand, 90112
    • Songklanagarind Hospital; Division of Gastroenterology
• United Arab Emirates
  • Dubai, United Arab Emirates, 4545
    • Rashid Hospital; Gastroenterology
• United Kingdom
  • Hull, United Kingdom, HU3 2JZ
    • Hull Royal Infirmary; Department Hepatology and Gastroenterology
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, E1 1BB
    • The Royal London Hospital
  • London, United Kingdom, W2 1PG
    • Imperial College Healthcare Trust
  • London, United Kingdom, SW17 0QT
    • St. Georges Uni of London; Gastroenterology & Hepatology
  • London, United Kingdom, W1 1TF
    • University College London; Hepatology
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Infirmary; Department Of Medicine

Participation Criteria

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

Patients with chronic hepatitis C receiving treatment with peginterferon alfa-2a 40KD (Pegasys)

Description

Inclusion Criteria:

• adult patient, >/= 18 years of age
• chronic hepatitis B
• treatment with peginterferon alfa-2A

Exclusion Criteria:

• coinfection with HAV, HCV and HIV

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance	Percentage of participants who became Hepatitis B Virus Surface Antigen (HBsAg) negative by the end of the observation period. A participant was considered to have achieved HBsAg clearance if the HBsAg measurement was reported as: (a) 'Negative' or (b) a quantitative result lower than the reported lower limit of detection. An observational period was upto 3 years post-treatment. The analysis was performed by 2 methods: Analysis A and Analysis B. For analysis A, all participants included in the analyzed population were used (participants with missing measurement for calculation of the endpoint were considered non-responders regarding the endpoint). For analysis B method, only participants in the analyzed population without missing measurements for calculation of the endpoint were used (analysis "as observed").	Up to 276 Weeks
Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Positive Participants	The probability that the participant who develops an early virological/serological response would achieve Hepatitis B Surface Antigen (HBsAg) clearance 3 years post-treatment is called the positive predictive value (PPV) of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the negative predictive value (NPV) of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg positive participant, HBsAg <1,500 International Units Per Milliliter (IU/mL) and HBsAg <20,000 IU/mL at Weeks 12 and 24.	Up to 276 Weeks
Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Negative Participants	The probability that the participant who develops an early virological/serological response would achieve HBsAg clearance 3 years post-treatment is called the PPV of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the NPV of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg negative patients, any decline in HBsAg from baseline to Week 12 and 24 and at least a 10% decline in HBsAg from baseline to Weeks 12 and 24.	Up to 276 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid to <2,000 International Units Per Milliliter	A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.	Up to 276 Weeks
Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion in Hepatitis B Virus e Antigen Positive Participants	HBeAg seroconversion is presented as percentage of participants who become HBeAg negative and anti-HBe positive. A participant was considered to have achieved HBeAg seroconversion if (a) the participant achieved HBeAg loss and (b) the anti-HBe measurement was reported as (i) 'POSITIVE' or (ii) a quantitative result considered 'positive' in the context. HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL: A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL. Abbreviations for pt=post-treatment.	Up to 276 Weeks
Percentage of Participants With Hepatitis B Virus e Antigen Loss in Hepatitis B Virus e Antigen Positive Participants	A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) 'NEGATIVE' or (b) a quantitative result was lower than the reported lower detection limit. This endpoint was measured in the participants with HBeAg positive CHB.	Up to 276 Weeks
Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid <2000IU/mL in Hepatitis B Virus e Antigen Positive Participants	A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL. If a patient received NUCs after end of PEG IFN treatment, then a reported suppression of HBV DNA to < 2,000 IU/mL during or after this NUC treatment were to be ignored, and HBV DNA ≥ 2,000 IU/mL was to be assigned. However, HBV DNA < 2,000 IU/mL was not to be ignored, if the NUC treatment given parallel to PEG IFN was discontinued within the first 8 weeks after end of PEG IFN treatment and prior to the HBV DNA value concerned no further NUCs were administered. Abbreviations for Seroconversion=sercnvrsn, Analysis A= AnalysA, and Analysis B= AnalysB, pt=post-treatment.	Up to 276 Weeks
Percentage of Participants With Hepatitis B Surface Antigen Seroconversion	Hepatitis B surface antigen (HBsAg) is a viral protein detectable in the blood in acute and chronic hepatitis B infection. A participant was considered to have achieved HBsAg seroconversion if (a) the participant achieved HBsAg clearance and (b) the last approved anti-HBs measurement in the analyzed time window was reported as i) 'POSITIVE' or (ii) quantitative result and was greater than or equal to the reported lower limit of detection.	Up to 276 Weeks
Quantitative Hepatitis B Surface Antigen	Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic hepatitis B participants. Last approved quantitative HBsAg measurement in the analyzed time window.	Up to 276 Weeks
Percentage of Participants With Normalization of Alanine Transaminase	A participant was considered to have achieved normalization of alanine transaminase (ALT) if the ALT measurement was lower or equal to the upper limit of the normal range. Only patients with elevated ALT at baseline were included in any analyses where normalization of ALT was used as endpoint. It was analyzed as last serum ALT in the analyzed time window, divided by the upper limit of the normal range.	Up to 276 Weeks
Alanine Transaminase Ratio Over Time by Hepatitis B Virus e Antigen Status	ALT ratio was calculated as serum ALT, divided by the upper limit of the normal range.	Up to 276 Weeks
Number of Participants With Chronic Hepatitis B - Associated Clinical Endpoints- Liver Transplantation, Hepatocellular Carcinoma, and Liver Decompensation	Number of clinical endpoints associated with CHB reported in the medical record, where data available, are reported. The clinical endpoints included liver transplantation, hepatocellular carcinoma, liver decompensation, development of cirrhosis (in patients without cirrhosis at baseline).	Up to 276 Weeks
Number of Participants With Chronic Hepatitis B Associated Clinical Endpoints- Liver Cirrhosis	Number of participants with clinical endpoints associated with CHB captured in the medical record, where data available, are reported. The clinical endpoints included development of cirrhosis (in participants without cirrhosis at baseline). The liver cirrhosis assessments were summarized from Week 12 to 3 years post-treatment.	Up to 276 Weeks
Number of Participants With Serious Adverse Drug Reactions	A serious adverse drug reactions (SADR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: Results in death, is life-threatening, NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect.	Up to 276 Weeks
Number of Participants With Non-Serious Adverse Drug Reactions	Non serious adverse drug reactions (NSADRs) are all noxious and unintended responses to a medicinal product related to any dose.	Up to 276 Weeks
Number of Participants With Adverse Events and Serious Adverse Events	An Adverse Events (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.	Up to 276 Weeks
Number of Deaths During Observation Period	The clinical endpoint of deaths due to any cause during observation period is presented.	Up to 276 Weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2009
• Primary Completion (Actual): November 18, 2014
• Study Completion (Actual): November 18, 2014

Study Registration Dates

• First Submitted: November 10, 2009
• First Submitted That Met QC Criteria: November 10, 2009
• First Posted (Estimate): November 11, 2009

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: March 10, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic
• Other Study ID Numbers: MV22009