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
8 de março de 2017 atualizado por: Hoffmann-La Roche
A Phase IV, Blood Sample Collection Study For Exploratory Evaluation of the Association of Single Nucleotide Polymorphisms With Treatment Responses From Subjects With HBe-Antigen Positive or Negative Chronic Hepatitis B, Who Received Therapy for Hepatitis B With Peginterferon Alfa-2a 40kD (Peg-IFN) ± Nucleos(t)Ide Analogue
This Phase 4 study is designed for the collection of blood biomarker samples from participants who have completed CHB treatment with at least 24 weeks of a pegylated interferon alfa-2a (Peg-IFN alfa-2a) containing regimen and at least 24 weeks post-treatment follow-up.
Participants may be enrolled from historical studies supported or sponsored by Roche, ongoing studies supported or sponsored by Roche, or from general medical practice.
The follow-up of individuals who choose to participate in this study will be in accordance with the ongoing studies or with the general medical practice of the physician.
Data from whole blood deoxyribonucleic acid (DNA) samples collected in the GV28555 study or available from previously collected Roche Clinical Repository (RCR) samples will be used for combined analysis with data from other applicable studies.
Procedures will include blood sample collection (not applicable for participants who previously have consented and donated RCR DNA samples) and medical record capture.
Visão geral do estudo
Status
Status
Concluído
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Tipo de estudo
Tipo de estudo
Observacional
Inscrição (Real)
Inscrição
1669
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Berlin, Alemanha, 13353
- Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie
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Berlin, Alemanha, 10117
- Praxis Dr. med. Christine John
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Berlin, Alemanha, 10969
- Praxis Dr. Heyne
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Hamburg, Alemanha, 20099
- Ifi- Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
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Hannover, Alemanha, 30625
- Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie
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Sofia, Bulgária, 1407
- MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
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Varna, Bulgária, 9010
- Mhat Sveta Marina; Clinic of Gastroenterology
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Beijing, China, 100044
- Peking University People's Hospital
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Beijing, China, 100011
- Beijing Ditan Hospital
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Beijing, China, 100039
- Beijing 302 Hospital; No. 2 Infectious Disease Section
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Beijing, China, 100069
- Beijing You An Hospital; Digestive Dept
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Changsha, China, 410008
- Xiangya Hospital of Centre-South University
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Chengdu, China, 610041
- West China Hospital, Sichuan University
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Chongqing, China, 400010
- The Second Affiliated Hospital, Chongqing Medical University
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Fu Zhou, China, 350005
- The First Affiliated Hospital of Fujian Medical University
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Guangzhou, China
- Guangdong General Hospital
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Guangzhou, China, 510515
- Nanfang Hospital, Southern Medical University
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Guangzhou, China, 510060
- The Eighth People's Hospital of Guangzhou
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Hangzhou, China
- Hangzhou Sixth People's Hospital
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Harbin, China, 150001
- The 1st Affiliated Hospital of Harbin Medical University
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Jinan, China, 250021
- JiNan Infectious Diseases Hospital
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Nanjing, China, 210003
- Nanjing No.2 Hospital; Liver Disease Department
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Nanning, China, 530021
- The First Affiliate Hospital of Guangxi Medical University
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Shanghai, China, 201508
- Shanghai Public Health Clinical Center
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Shanghai, China, 200021
- Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
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Shen Zhen, China, 518020
- Shenzhen Donghu Hospital
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Shi Jiazhuang, China, 050051
- The Third Hospital of Hebei Medical University
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Urumqi, China, 830001
- Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
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Wuhan, China, 430030
- Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
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Xi'an, China, 710038
- The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
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Yinchuan, China, 750004
- General Hospital of Ningxia Medical University
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Zhengzhou, China, 450003
- Henan Provincial People's Hospital
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Clichy, França, 92118
- Hopital Beaujon;Hepatologie
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Creteil, França, 94010
- Hopital Henri Mondor; Hepatologie Gastro Enterologie
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Rennes, França, 35033
- Hopital de Pontchaillou; Medicine Interne - Hepatologie
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Saint Laurent Du Var, França, 06721
- Institut Arnault Tzanck; Medecine I Gastro Enterologie
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Athens, Grécia, 115 27
- Laiko General Hospital Athen; Uni Clinic of Gastrenterology
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Larissa, Grécia, 41 110
- University Hospital of Larissa; Pathological Clinic
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Thessaloniki, Grécia, 546 42
- Hippokratio Hospital; 4Th Internal Medicine Dpt
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Campania
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Caserta, Campania, Itália, 81100
- Az. Osp. S. Sebastiano; Divisione Malattie Infettive
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Napoli, Campania, Itália, 80131
- Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia
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Emilia-Romagna
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Bologna, Emilia-Romagna, Itália, 40138
- UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
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Parma, Emilia-Romagna, Itália, 43100
- Az. Osp. Uni Ria Di Parma; Gastro-Enterology
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Lombardia
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Milano, Lombardia, Itália, 20122
- Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
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Milano, Lombardia, Itália, 20122
- Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale
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Puglia
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Bari, Puglia, Itália, 70124
- Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive
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Castellana Grotte, Puglia, Itália, 70013
- Ospedale de Bellis; Reparto Medicina Generale
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Sardegna
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Cagliari, Sardegna, Itália, 09042
- Uni Di Cagliari; Dept. Di Scienze Mediche
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Sicilia
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Palermo, Sicilia, Itália, 90127
- Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia
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Toscana
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Pisa, Toscana, Itália, 56124
- Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
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Veneto
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Padova, Veneto, Itália, 35128
- Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.
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Auckland, Nova Zelândia, 100
- Auckland Hospital; New Zealand Liver Transplant Unit
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Bydgoszcz, Polônia, 85-030
- Hospital For Infectious Diseases; Infectiology
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Chorzow, Polônia, 41-500
- Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny
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Krakow, Polônia, 31-202
- Krakowski Szpital Specjalistyczny im. Jana Pawla II; Oddzial Wirusowego Zapalenia Watroby
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Lancut, Polônia, 37-100
- Centrum Medyczne
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Warszawa, Polônia, 02-507
- Centralny Szpital Kliniczny MSWiA; Oddzial Chorob Wewnetrznych i Hepatologii
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Warszawa, Polônia, 01-201
- Wojewodzki Szpital Zakazny; Klinika Chorob Zakaznych
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Zielona Góra, Polônia, 65-044
- NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby
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Łodz, Polônia, 91-347
- Specjalistyczny Szpital Wojewódzki im. Biegańskiego; Klinika Chorób Zakaźnych i Hepatologii UM
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Lisboa, Portugal, 1649-035
- Hospital de Santa Maria; Servico de Gastrenterologia e Hepatologia
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Porto, Portugal, 4099-001
- Hospital Geral de Santo Antonio; Servico de Gastrenterologia
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Porto, Portugal, 4202-451
- Hospital de Sao Joao; Servico de Gastrenterologia
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London, Reino Unido, E1 1BB
- The Royal London Hospital
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Manchester, Reino Unido, M13 9WL
- Manchester Royal Infirmary; Department Of Medicine
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Busan, Republica da Coréia, 633-165
- Inje University Busan Paik Hospital; Nephrology
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Chooncheon, Republica da Coréia, 200-060
- Chooncheon Sacred Heart Hospital
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Seoul, Republica da Coréia, 135-710
- Samsung Medical Center; Gastroenterology
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Bucharest, Romênia, 021105
- Institutul De Boli Infectioase Matei Bals; Sectia Clinica II Boli Infectioase Adulti
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Bucharest, Romênia, 030303
- The Hospital of Tropical and Infectious Disease Victor Babes
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Craiova, Romênia, 200515
- Clinical Infectious Diseases Hospital Victor Babes
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Bangkok, Tailândia, 10700
- Siriraj Hospital
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Chiang Mai, Tailândia, 50200
- Chiang Mai Uni Hospital; Faculty of Medicine
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Songkhla, Tailândia, 90112
- Songklanagarind Hospital; Division of Gastroenterology
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Changhua, Taiwan, 500
- Changhua Christian Hospital; Internal Medicine
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Kaohsiung, Taiwan, 807
- Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
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Kaohsiung, Taiwan, 00833
- Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
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Keelung City, Taiwan, 204
- Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
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Taichung, Taiwan, 404
- China Medical University Hospital; Department of Rheumatology
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital; Gastroenterology Division
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Taipei, Taiwan, 100
- National Taiwan Uni Hospital; Gastro-Enterology Dept.
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Taipei, Taiwan
- Tri-Service Hospital; Dept. of Internal Medicine
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Taoyuan, Taiwan, 333
- Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
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Wien, Áustria, 1090
- Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
Participants with CHB who received therapy with Peg-IFN ± nucleoside/nucleotide analogue will be included.
Descrição
Inclusion Criteria:
- Adults greater than or equal to (≥) 18 years of age
- 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:
- Hepatitis A, hepatitis C, or human immunodeficiency virus (HIV) infection
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Número de grupos/coortes
1
Coortes e Intervenções
Grupo / CoorteGrupo / Coorte |
Intervenção / TratamentoIntervenção / Tratamento |
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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.
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
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Genome-wide association study (GWAS) approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of the antibody to HBeAg (anti-HBe).
HBsAg clearance was defined as the loss of HBsAg, with or without detection of the antibody to HBsAg (anti-HBs).
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
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Single blood sample ≥24 weeks post-treatment
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SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
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SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
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Single blood sample ≥24 weeks post-treatment
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SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
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GWAS approach was used to evaluate association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as HBV DNA level below the lower limit of detection (LLD) of 2000 international units per milliliter (IU/mL).
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
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SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
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SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
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SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
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Single blood sample ≥24 weeks post-treatment
|
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SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
Only a single SNP (rs17037122) was included in the analysis.
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Single blood sample ≥24 weeks post-treatment
|
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SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
Only a single SNP (rs17037122) was included in the analysis.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
Only a single SNP (rs2464266) was included in the analysis.
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Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
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SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
Only a single SNP (rs17037122) was included in the analysis.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
Only a single SNP (rs12992677) was included in the analysis.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
Only a single SNP (rs12992677) was included in the analysis.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
Only a single SNP (rs7549785) was included in the analysis.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
Only a single SNP (rs7549785) was included in the analysis.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to additive models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant Model
Prazo: Single blood sample ≥24 weeks post-treatment
|
GWAS approach was used to evaluate the association of SNPs with treatment response.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Associations with treatment response were analyzed using logistic regression and adjusted for covariates.
Markers were coded according to dominant models of inheritance.
Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively.
Larger beta coefficients correspond to greater likelihood of treatment response.
Only a single SNP (rs6592052) was included in the analysis.
|
Single blood sample ≥24 weeks post-treatment
|
Outras medidas de resultado
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe.
Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
|
Single blood sample ≥24 weeks post-treatment
|
|
Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population
Prazo: Single blood sample ≥24 weeks post-treatment
|
Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment.
HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.
|
Single blood sample ≥24 weeks post-treatment
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
20 de agosto de 2013
Conclusão Primária (Real)
Conclusão Primária
28 de novembro de 2014
Conclusão do estudo (Real)
Conclusão do estudo
28 de novembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
8 de maio de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de maio de 2013
Primeira postagem (Estimativa)
Primeira postagem
17 de maio de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
5 de abril de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de março de 2017
Última verificação
Última verificação
1 de março de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções transmitidas pelo sangue
- Doenças Transmissíveis
- Doenças do Fígado
- Hepatite, Viral, Humana
- Infecções Hepadnaviridae
- Infecções por vírus de DNA
- Infecções por Enterovírus
- Infecções por Picornaviridae
- Hepatite Crônica
- Hepatite B
- Hepatite
- Hepatite A
- Hepatite B Crônica
- Agentes Anti-Infecciosos
- Antivirais
- Agentes Antineoplásicos
- Peginterferon alfa-2a
- Interferon alfa-2
Outros números de identificação do estudo
Outros números de identificação do estudo
- GV28855
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .