Hepatitis B, ChronicNCT01011738
An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys
An observational study of Hepatitis B, Chronic, run by Hoffmann-La Roche at 249 sites in 27 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 1,842 participants
- Where
- 249 sitesin 27 countries
- Study dates
- 11 Apr 2009to 18 Nov 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients with chronic hepatitis C receiving treatment with peginterferon alfa-2a 40KD (Pegasys)
Who may be able to join
- adult patient, >/= 18 years of age
- chronic hepatitis B
- treatment with peginterferon alfa-2A
Who cannot join
- coinfection with HAV, HCV and HIV
Trial locations and contacts
249 sites in 27 countries.
249 sites in 27 countries
France65 sites
Ch Du Pays D Aix; Gastro Enterologie
Aix-en-Provence, 13616
Hopital Nord; Medecine A
Amiens, 80054
Hopital Nord; Reseau Hepatologie Picardie
Amiens, 80054
Hotel Dieu; Medecine A
Angers, 49033
Ch Victor Dupouy; Hepato Gastro Medecine Interne
Argenteuil, 95107
Ch Victor Dupouy; Oncologie
Argenteuil, 95107
Ch Henri Duffaut;Gastro Enterologie
Avignon, 84902
Hopital Jean Minjoz; Hepatologie
Besançon, 25030
Hopital Avicenne; Unite D Hepatologie
Bobigny, 93009
Hopital Jean Verdier; Gastro Enterologie
Bondy, 93143
Hopital Saint Andre; Hepato-Gastro-Enterologie
Bordeaux, 33000
Ch Pierre Oudot; Gastro Enterologie
Bourgoin, 38317
Hopital Cote De Nacre; Gastro Enterologie
Caen, 14033
Hopital Trousseau; Gastro Enterologie A Et B
Chambray-lès-Tours, 37171
Hopital Antoine Beclere; Hepatologie Gastro Enterologie
Clamart, 92141
Chu Estaing; Medecine Digestive
Clermont-Ferrand, 63003
Hopital Beaujon; Gastro Enterologie 1
Clichy, 92118
Hopital Beaujon;Hepatologie
Clichy, 92118
Ch Sud Francilien; Cons Gastro Enterologie
Corbeil-Essonnes, 91106
Ch Laennec; Medecine IV
Creil, 60109
Hopital Henri Mondor; Hepatologie Gastro Enterologie
Créteil, 94010
Hopital Du Bocage; Gastro Enterologie
Dijon, 21079
Ch Sud Francilien; Gastro Enterologie
Évry, 91014
CABINET
Grasse, 06130
Hopital Albert Michallon; Gastro Enterologie
La Tronche, 38700
Ch De Lagny Sur Marne; Gastro Enterologie
Lagny-sur-Marne, 77405
Ch De Bicetre; Gastro Enterologie
Le Kremlin-Bicêtre, 94275
Ch Du Mans; Medecine Ii
Le Mans, 72037
Hopital Claude Huriez;Gastro Enterologie
Lille, 59037
Hopital Dupuytren; Medecine Interne A
Limoges, 87042
Clinique De La Sauvegarde; Exploration Gastro Proctologie
Lyon, 69009
Hopital Hotel Dieu; Medecine Interne & D'Hepatologie
Lyon, 69288
Hopital De La Croix Rousse; Hepatologie Gastro Enterologie
Lyon, 69317
Fondation Hopital Saint Joseph; Gastro-Enterologie
Marseille, 13285
Hopital De La Conception; Gastro Enterologie Endoscopie 2E Nord
Marseille, 13385
Hopital De La Conception; Rhumatologie
Marseille, 13385
Hopital N D Bon Secours; Medecine B2
Metz, 57038
Ch De Montauban; Medecine Interne
Montauban, 82013
Hopital Jacques Monod; Gastro-Enterologie
Montivilliers, 76290
Cabinet Medical
Montpellier, 34070
Hopital Saint-Eloi; Hepatologie-Gastro-Enterologie
Montpellier, 34295
Hopital Emile Muller; Gastro Enterologie
Mulhouse, 68070
Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie
Nantes, 44093
Cabinet
Nantes, 44200
Hopital Caremeau; Gastro Enterologie
Nîmes, 30029
Ch Georges Renon; Maladies Infectieuses
Niort, 79021
Hopital La Source; Medecine H
Orléans, 45100
Fondation Institut Arthur Vernes; Institut Arthur Vernes
Paris, 75006
Hopital Saint Antoine; Hepatologie-Gastr-Enterologie
Paris, 75571
CH Pitie Salpetriere; Hepathologie Gastro Enterologie
Paris, 75651
Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie
Paris, 75877
Hopital Saint Jean; Hematologie
Perpignan, 66046
Hopital Du Haut-Leveque; Gastro-Enterologie
Pessac, 33604
Hopital Robert Debre; Gastro Enterologie
Reims, 51092
Hopital de Pontchaillou; Medicine Interne - Hepatologie
Rennes, 35033
Hopital Charles Nicolle; Gastro Enterologie
Rouen, 76031
Institut Arnault Tzanck; Medecine I Gastro Enterologie
Saint-Laurent-du-Var, 06721
Hopital Esquirol; Cons Externes
Saint-Maurice, 94413
Hopital Civil; Hepatologie-Gastro-Enterologie
Strasbourg, 67091
Cabinet Medical Gastro Enterologie
Toulon, 83000
Hopital Font Pre; Gastro Enterologie
Toulon, 83056
Hopital Purpan;Gastro Enterologie Hepatologie
Toulouse, 31059
Clinique Ambroise Pare; Medecine
Toulouse, 31082
Hopitaux de Brabois - Gastro-Entereologie
Vandœuvre-lès-Nancy, 54511
Hopital Paul Brousse; Centre Hepatologie Biliaire
Villejuif, 94804
Germany37 sites
Charité Universitätsmedizin Berlin; Campus Mitte, Centrum 12, Medizinische Poliklinik
Berlin, 10117
Praxis Dr. med. Christine John
Berlin, 10117
überörtl.Gem.Praxis Dres. Stephan Dupke Axel Baumgarten
Berlin, 10439
Dres.Bernd Möller und Renate Heyne
Berlin, 10969
Praxis Dr. Heyne
Berlin, 10969
Charité - Campus Benjamin Franklin; Zentrum fuer Innere Medizin, Med. Klinik I
Berlin, 12203
Campus Virchow-Klinikum Charité Centrum 13; Medizinische Klinik; Abt.Hepatologie u.Gastroenterologie
Berlin, 13353
CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie
Berlin, 13353
Dres. Jörg Gölz und Arend Moll
Berlin, 14057
Universitätsklinikum Bonn Med. Klinik u. Poliklinik I
Bonn, 53127
Universitätsklinikum Klinik f. Gastroenterologie Hepatologie und Infektiologie
Düsseldorf, 40225
Universitätsklinikum Erlangen; Medizinische Klinik 1
Erlangen, 91054
Universitaetsklinikum Essen, Innere Klinik und Poliklinik fuer Tumorforschung
Essen, 45122
Praxis PD Dr.med. Gerlinde Teuber
Frankfurt am Main, 60594
Universitätsklinikum Freiburg Medizinische Klinik Innere Medizin I
Freiburg im Breisgau, 79106
Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik II
Giessen, 35392
Med. Versorgungszentrum ifi-Institut
Hamburg, 20099
Infektionsmedizinisches Centrum Hamburg ICH Grindel
Hamburg, 20146
St.Marien-Hospital Klinik Knappenstraße Klinik f.Gastroenterologie
Hamm, 59071
Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie
Hanover, 30625
Uni Heidelberg Med. Klinik; Innere Medizin IV
Heidelberg, 69120
Dres.Dietrich Hüppe Gisela Felten und Heinz Hartmann
Herne, 44623
Universitätsklinikum Jena; Klinik für Innere Medizin II
Jena, 07747
Universitätsklinikum S.-H. Campus Kiel Klinik für Innere Medizin I Gastroenterologie Hepotologie
Kiel, 24105
Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Transplantationszentrum
Lübeck, 23562
Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie
Magdeburg, 39120
Uniklinik Mainz; I. Medizinische Klinik
Mainz, 55131
Klinikum rechts der Isar der TU München; II. Medizinische Klinik & Poliklinik
München, 81675
Dr.med.Heiner W.Busch und Stefan Christensen
Münster, 48143
Universitätsklinikum Münster Klinik und Poliklinik für Transplantationsmedizin
Münster, 48149
Klinikum Nord Medizinische Klinik 6
Nuremberg, 90419
St. Josefs Klinik; Medizinische Klinik
Offenburg, 77654
Klinikum Salzgitter-Lebenstedt Medizinische Klinik I
Salzgitter, 38226
Dres. Andreas Schaffert Andreas Trein und Edith Ißler u.w.
Stuttgart, 70197
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
Ulm, 89081
Praxis Sabine Mauruschat
Wuppertal, 42277
Medizinische Universitätsklinik; Med. Klinik Ii, Infektiologie
Würzburg, 97080
China23 sites
Beijing Ditan Hospital
Beijing, 100011
Beijing 302 Hospital; No. 2 Infectious Disease Section
Beijing, 100039
Peking University People's Hospital
Beijing, 100044
Beijing You An Hospital; Digestive Dept
Beijing, 100069
West China Hospital, Sichuan University
Chengdu, 610041
The Second Affiliated Hospital, Chongqing Medical University
Chongqing, 400010
The Eighth People's Hospital of Guangzhou
Guangzhou, 510060
Guangdong General Hospital
Guangzhou
Hangzhou Sixth People's Hospital
Hangzhou
The 1st Affiliated Hospital of Harbin Medical University
Harbin, 150001
Jinan Infectious Diseases Hospital
Jinan, 250021
Nanjing No.2 Hospital; Liver Disease Department
Nanjing, 210003
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Huashan Hospital Affiliated to Fudan University
Shanghai, 200040
The 85th Hospital of P.L.A.
Shanghai, 200235
Shanghai Public Health Clinical Center
Shanghai, 201508
Shengjing Hospital of China Medical University
Shenyang, 110004
Shenzhen Donghu Hospital
Shenzhen, 518020
The Third Hospital of Hebei Medical University
Shijiazhuang, 050051
Bethune International Peace Hospital of PLA
Shijiazhuang, 050082
Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
Ürümqi, 830001
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, 325000
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, 710038
South Korea15 sites
Pyungchon Sacred Heart Hospital
Anyang, 431-070
Pusan University Hospital
Busan, 602-739
Inje University Pusan Paik Hospital
Busan, 614-735
Chooncheon Sacred Heart Hospital
Chooncheon, 200-060
Kyungpook National Uni Hospital; Internal Medicine
Daegu, 700-721
Chungnam University Hospital
Daejeon, 301-846
Inha University Hospital
Incheon, 22332
Chonbuk National Uni Hospital
Jeollabuk-do, 561-712
Eulji General Hospital
Seoul, 01830
ChungAng University Hospital
Seoul, 06973
Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept.
Seoul, 120-752
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, 135-710
Korea Kuro Hospital; Internal Medicine
Seoul
Pundang Jesaeng General Hospital
Seoungnamsi, 463-824
Ulsan University Hosiptal
Ulsan, 44033
Poland13 sites
Medical Uni of Bialystok; Infectious Diseases
Bialystok, 15-540
Hospital For Infectious Diseases; Infectiology
Bydgoszcz, 85-030
Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny
Chorzów, 41-500
Pomorskie Centrum Chorob Zakaznych i Gruzlicy
Gdansk, 80-214
Krakowski Szpital Specjalistyczny im. Jana Pawla II; Oddzial Wirusowego Zapalenia Watroby
Krakow, 31-202
Centrum Medyczne
Łańcut, 37-100
Medical Uni of Lodz; Infectious Diseases
Lodz, 91-347
Specjalistyczny Szpital Wojewódzki im. Biegańskiego; Klinika Chorób Zakaźnych i Hepatologii UM
Lodz, 91-347
Wojewódzki specjalistyczny szpital im. Bieganskiego; Oddział Obserwacyjno-Zakazny i Chorob Watroby
Lodz, 91-347
Inst. of Infectious & Parasitic Diseases; Clinic of Hepatology & Aquired Immunodeficiencies
Warsaw, 01-201
Centralny Szpital Kliniczny MSWiA; Oddzial Chorob Wewnetrznych i Hepatologii
Warsaw, 02-507
Wojewodzki Szpital; Specjalistyczny Chorob Zakaznych
Wroclaw, 51-124
NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby
Zielona Góra, 65-044
Indonesia12 sites
Boromeus Hospital; Hepatology
Bandung, 40132
Santosa Bandung International Hospital; Hepatology
Bandung, 40181
Hasan Sadikin Hospital; Digestive Surgery
Bandung
Klinik Hati; Hepatology
Jakarta, 10150
PGI Cikini Hospital; Hepatology
Jakarta, 10330
Central Army Hospital Rspad Gatot Soebroto; Pulmonology
Jakarta, 10410
Cipto Mangunkusumo General Hospital; Hematology & Oncology
Jakarta, 10430
Medistra Hospital; Hepatology
Jakarta, 12950
Mitra International Jatinegara Hospital; Hepatology
Jakarta, 13310
Klinik Kimia Farma
Jakarta, 13430
Dr. Soetomo Hospital; Kidney and Hipertansion
Surabaya, 60286
Bintaro International Hospital, Hepatology
Tangerang, 15224
Pakistan10 sites
Allied Hospital; Department of Medicine
Faisalabad
Islamabad Specialist Clinic
Islamabad
Akbar Center
Karachi
Dow University of Health Sciences; Department of Medicine
Karachi
Medicare Clinics
Karachi
Sheikh Zayed Hospital; Department of Gastroentrology
Lahore, 20021
Kanaan Clinic
Lahore, 54500
Saeed Anwar Medical Centre
Peshawar
Combined Military Hospital; Department of Medicine
Rawalpindi
Holy Family Hospital; Department of Medicine
Rawalpindi
Egypt8 sites
Gamal Sheha Clinic
Al Mansurah, 0
Dr. Ibrahim Mostafa Clinic
Cairo, 0
Yehia Elshazly Clinic for Hepatology and Gastroentrology
Cairo, 0
Dr.Mohamed Amr Affifi Clinic
Cairo
Dr.Nabil Fawzy private clinic
Cairo
Dr.Nadia Elansary Clinic
Cairo
Dr. Taher Elzanaty clinic
Giza, 0
Dr. Ahmed Monis Clinic
Giza
India8 sites
Medanta -The Medicity; Department of Digestive and Hepatobiliary Sciences
Gūrgaon
Institute of Digestive Diseases
Guwahati, 781005
Opp Jaslok Hospital
Mumbai, 400036
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, 110076
Krishnai Clinic
Pune, 411004
Medipoint Clinic
Pune, 411004
Pai Clinic and Diagnostic Center
Pune, 411005
Sree Gokulam Medical College and Research Foundation
Trivandrum, 695 001
Bosnia and Herzegovina7 sites
Clinical Center Banja Luka; Department for Infective Diseases
Banja Luka, 78000
Cantonal Hospital Bihac; Department for Infective Diseses
Bihać, 77000
Clinical Hospital Mostar; Department for Gastroenterology
Mostar, 88000
Clinical Center Sarajevo; Gastroenterohepatology
Sarajevo, 71000
University Clinical Center Tuzla; Clinic for Gastroenterology
Tuzla, 75000
University Clinical Center Tuzla; Clinic for Infective Diseases
Tuzla, 75000
Cantonal Hospital Zenica; Department for Infective Diseases
Zenica, 72000
United Kingdom7 sites
Hull Royal Infirmary; Department Hepatology and Gastroenterology
Hull, HU3 2JZ
The Royal London Hospital
London, E1 1BB
King'S College Hospital
London, SE5 9RS
St. Georges Uni of London; Gastroenterology & Hepatology
London, SW17 0QT
University College London; Hepatology
London, W1 1TF
Imperial College Healthcare Trust
London, W2 1PG
Manchester Royal Infirmary; Department Of Medicine
Manchester, M13 9WL
Austria5 sites
Lkh-Univ. Klinikum Graz
Graz, 8036
Tiroler Landeskrankenanstalten Ges.M.B.H.; Klinische Abt. Für Gaströnterologie & Hepatologie
Innsbruck, 6020
A.Ö. Krankenhaus Der Elisabethinen Linz; Iv. Med. Abtl.
Linz, 4010
Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
Vienna, 1090
Wilhelminenspital; Iv. Medizinische Abt.
Vienna, 1160
Romania5 sites
Cantacuzino Clinical Hospital;Gastroenterology Department
Bucharest, 020475
Institutul De Boli Infectioase Matei Bals; Sectia Clinica II Boli Infectioase Adulti
Bucharest, 021105
The Hospital of Tropical and Infectious Disease Victor Babes
Bucharest, 030303
Clinical Infectious Diseases Hospital Victor Babes
Craiova, 200515
Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor; INFECTIOUS DISEASE
Craiova, 200515
Saudi Arabia5 sites
King Fahad University Hospital; Internal Medicine
Khobar, 31952
Riyadh Military Hospital
Riyadh, 11159
King Faisal Specialist Hospital & Research Centre; Oncology
Riyadh, 11211
King Fahad Medical City; Gastroentrology
Riyadh, 11525
North West Armed Forces Hospital; Internal Medicine
Tabuk, 71411
Jordan3 sites
Al-Bashir Hospital
Amman, 1005
Prince Hamzeh Hospital; Internal Medicine
Amman, 86 / 11118
King Abdullah University Hospital
Irbid, 360001
Lebanon3 sites
American University of Beirut - Medical Center
Beirut, 11-236
Beirut Governmental University Hospital
Beirut, 99999
Hotel-Dieu de France Hospital; Gastroenterology
Beirut, 99999
Morocco3 sites
Cabinet Privé Pr D Jamil
Casablanca, 20100
CHU Hassan 2; Service Gastro Enterologie Pr IBRAHIMI
Fes, 30003
Centre Hospitalier Universitaire Ibn Sina; Service de Gastro-entérologie Essaid
Rabat, 504
New Zealand3 sites
Auckland Hospital; New Zealand Liver Transplant Unit
Auckland, 100
Waikato Hospital; Gastroenterology
Hamilton
Hepatitis Foundation
Whakatane
Portugal3 sites
Hospital de Santa Maria; Servico de Gastrenterologia e Hepatologia
Lisbon, 1649-035
Hospital Geral de Santo Antonio; Servico de Gastrenterologia
Porto, 4099-001
Hospital de Sao Joao; Servico de Gastrenterologia
Porto, 4202-451
Thailand3 sites
Siriraj Hospital
Bangkok, 10700
Chiang Mai Uni Hospital; Faculty of Medicine
Chiang Mai, 50200
Songklanagarind Hospital; Division of Gastroenterology
Songkhla, 90112
Bangladesh2 sites
Liver Clinic Lab-Aid Specialized Hospital
Dhaka, 1205
The Liver Centre
Dhaka, 1209
Bulgaria2 sites
MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
Sofia, 1407
Mhat Sveta Marina; Clinic of Gastroenterology
Varna, 9010
Ireland2 sites
Mater Misericordiae University Hospital;Gastrointestinal Unit/Center for Liver Disease
Dublin, 7
St. James Hospital; Hepatology
Dublin, 8
North Macedonia2 sites
Clinical Center Skopje; Gastroenterohepatology
Skopje, 1000
Clinical Center Skopje; Infectious Diseases
Skopje, 1000
United Arab Emirates1 site
Rashid Hospital; Gastroenterology
Dubai, 4545
About this study
Official title: 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.
- Conditions
- Hepatitis B, Chronic
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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.
Measured: 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.
Measured: Up to 276 Weeks
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 276 Weeks
Number of Deaths During Observation Period
The clinical endpoint of deaths due to any cause during observation period is presented.
Measured: Up to 276 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study start11 Apr 2009
- Primary completion18 Nov 2014
- Study completion18 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,842 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011738
- Sponsor's protocol ID
- MV22009
- Status last verified
- Mar 2017
- First submitted
- 10 Nov 2009
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01011738
- Acronym / sponsor ID
- MV22009
- Conditions
- Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,842 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2009 (actual)
- Primary completion
- 18 Nov 2014 (actual)
- Study completion
- 18 Nov 2014 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Posted 8 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C receiving treatment with peginterferon alfa-2a 40KD (Pegasys)
Key inclusion criteria (3 listed)
- adult patient, >/= 18 years of age
- chronic hepatitis B
- treatment with peginterferon alfa-2A
Key exclusion criteria (1 listed)
- coinfection with HAV, HCV and HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance
Time frame: Up to 276 Weeks
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").
Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Positive Participants
Time frame: Up to 276 Weeks
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.
Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Negative Participants
Time frame: Up to 276 Weeks
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.
14 secondary outcomes
Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid to <2,000 International Units Per Milliliter
Time frame: Up to 276 Weeks
Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion in Hepatitis B Virus e Antigen Positive Participants
Time frame: Up to 276 Weeks
Percentage of Participants With Hepatitis B Virus e Antigen Loss in Hepatitis B Virus e Antigen Positive Participants
Time frame: 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
Time frame: Up to 276 Weeks
Percentage of Participants With Hepatitis B Surface Antigen Seroconversion
Time frame: Up to 276 Weeks
Quantitative Hepatitis B Surface Antigen
Time frame: Up to 276 Weeks
Percentage of Participants With Normalization of Alanine Transaminase
Time frame: Up to 276 Weeks
Alanine Transaminase Ratio Over Time by Hepatitis B Virus e Antigen Status
Time frame: Up to 276 Weeks
Number of Participants With Chronic Hepatitis B - Associated Clinical Endpoints- Liver Transplantation, Hepatocellular Carcinoma, and Liver Decompensation
Time frame: Up to 276 Weeks
Number of Participants With Chronic Hepatitis B Associated Clinical Endpoints- Liver Cirrhosis
Time frame: Up to 276 Weeks
Number of Participants With Serious Adverse Drug Reactions
Time frame: Up to 276 Weeks
Number of Participants With Non-Serious Adverse Drug Reactions
Time frame: Up to 276 Weeks
Number of Participants With Adverse Events and Serious Adverse Events
Time frame: Up to 276 Weeks
Number of Deaths During Observation Period
Time frame: Up to 276 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatitis B, Chronic
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)
Chronic Hepatitis B Virus (HBV) Infection
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Not yet recruitingPhase 1
A Clinical Study of AHB-121 in Healthy Participants and Chronic Hepatitis B (CHB) Participants
Chronic Hepatitis B Virus
Not yet recruitingPhase 1/2
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
249 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by Hoffmann-La Roche at 249 sites in 27 countries.
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 3 inclusion and 1 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 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 249 sites in France, Germany, China, South Korea, Poland and 22 more countries. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance (time frame: Up to 276 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2017.