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 mars 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Réel)
1669
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Berlin, Allemagne, 13353
- Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie
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Berlin, Allemagne, 10117
- Praxis Dr. med. Christine John
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Berlin, Allemagne, 10969
- Praxis Dr. Heyne
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Hamburg, Allemagne, 20099
- Ifi- Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
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Hannover, Allemagne, 30625
- Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie
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Sofia, Bulgarie, 1407
- MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
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Varna, Bulgarie, 9010
- Mhat Sveta Marina; Clinic of Gastroenterology
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Beijing, Chine, 100044
- Peking University People's Hospital
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Beijing, Chine, 100011
- Beijing Ditan Hospital
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Beijing, Chine, 100039
- Beijing 302 Hospital; No. 2 Infectious Disease Section
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Beijing, Chine, 100069
- Beijing You An Hospital; Digestive Dept
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Changsha, Chine, 410008
- Xiangya Hospital of Centre-South University
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Chengdu, Chine, 610041
- West China Hospital, Sichuan University
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Chongqing, Chine, 400010
- The Second Affiliated Hospital, Chongqing Medical University
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Fu Zhou, Chine, 350005
- The First Affiliated Hospital of Fujian Medical University
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Guangzhou, Chine
- Guangdong General Hospital
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Guangzhou, Chine, 510515
- Nanfang Hospital, Southern Medical University
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Guangzhou, Chine, 510060
- The Eighth People's Hospital of Guangzhou
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Hangzhou, Chine
- Hangzhou Sixth People's Hospital
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Harbin, Chine, 150001
- The 1st Affiliated Hospital of Harbin Medical University
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Jinan, Chine, 250021
- JiNan Infectious Diseases Hospital
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Nanjing, Chine, 210003
- Nanjing No.2 Hospital; Liver Disease Department
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Nanning, Chine, 530021
- The First Affiliate Hospital of Guangxi Medical University
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Shanghai, Chine, 201508
- Shanghai Public Health Clinical Center
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Shanghai, Chine, 200021
- Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
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Shen Zhen, Chine, 518020
- Shenzhen Donghu Hospital
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Shi Jiazhuang, Chine, 050051
- The Third Hospital of Hebei Medical University
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Urumqi, Chine, 830001
- Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
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Wuhan, Chine, 430030
- Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
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Xi'an, Chine, 710038
- The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
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Yinchuan, Chine, 750004
- General Hospital of Ningxia Medical University
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Zhengzhou, Chine, 450003
- Henan Provincial People's Hospital
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Busan, Corée, République de, 633-165
- Inje University Busan Paik Hospital; Nephrology
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Chooncheon, Corée, République de, 200-060
- Chooncheon Sacred Heart Hospital
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Seoul, Corée, République de, 135-710
- Samsung Medical Center; Gastroenterology
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Clichy, France, 92118
- Hopital Beaujon;Hepatologie
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Creteil, France, 94010
- Hopital Henri Mondor; Hepatologie Gastro Enterologie
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Rennes, France, 35033
- Hopital de Pontchaillou; Medicine Interne - Hepatologie
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Saint Laurent Du Var, France, 06721
- Institut Arnault Tzanck; Medecine I Gastro Enterologie
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Athens, Grèce, 115 27
- Laiko General Hospital Athen; Uni Clinic of Gastrenterology
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Larissa, Grèce, 41 110
- University Hospital of Larissa; Pathological Clinic
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Thessaloniki, Grèce, 546 42
- Hippokratio Hospital; 4Th Internal Medicine Dpt
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Campania
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Caserta, Campania, Italie, 81100
- Az. Osp. S. Sebastiano; Divisione Malattie Infettive
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Napoli, Campania, Italie, 80131
- Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italie, 40138
- UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
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Parma, Emilia-Romagna, Italie, 43100
- Az. Osp. Uni Ria Di Parma; Gastro-Enterology
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Lombardia
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Milano, Lombardia, Italie, 20122
- Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
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Milano, Lombardia, Italie, 20122
- Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale
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Puglia
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Bari, Puglia, Italie, 70124
- Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive
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Castellana Grotte, Puglia, Italie, 70013
- Ospedale de Bellis; Reparto Medicina Generale
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Sardegna
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Cagliari, Sardegna, Italie, 09042
- Uni Di Cagliari; Dept. Di Scienze Mediche
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Sicilia
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Palermo, Sicilia, Italie, 90127
- Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia
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Toscana
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Pisa, Toscana, Italie, 56124
- Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
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Veneto
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Padova, Veneto, Italie, 35128
- Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.
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Wien, L'Autriche, 1090
- Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
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Lisboa, Le Portugal, 1649-035
- Hospital de Santa Maria; Servico de Gastrenterologia e Hepatologia
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Porto, Le Portugal, 4099-001
- Hospital Geral de Santo Antonio; Servico de Gastrenterologia
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Porto, Le Portugal, 4202-451
- Hospital de Sao Joao; Servico de Gastrenterologia
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Auckland, Nouvelle-Zélande, 100
- Auckland Hospital; New Zealand Liver Transplant Unit
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Bydgoszcz, Pologne, 85-030
- Hospital For Infectious Diseases; Infectiology
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Chorzow, Pologne, 41-500
- Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny
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Krakow, Pologne, 31-202
- Krakowski Szpital Specjalistyczny im. Jana Pawla II; Oddzial Wirusowego Zapalenia Watroby
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Lancut, Pologne, 37-100
- Centrum Medyczne
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Warszawa, Pologne, 02-507
- Centralny Szpital Kliniczny MSWiA; Oddzial Chorob Wewnetrznych i Hepatologii
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Warszawa, Pologne, 01-201
- Wojewodzki Szpital Zakazny; Klinika Chorob Zakaznych
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Zielona Góra, Pologne, 65-044
- NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby
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Łodz, Pologne, 91-347
- Specjalistyczny Szpital Wojewódzki im. Biegańskiego; Klinika Chorób Zakaźnych i Hepatologii UM
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Bucharest, Roumanie, 021105
- Institutul De Boli Infectioase Matei Bals; Sectia Clinica II Boli Infectioase Adulti
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Bucharest, Roumanie, 030303
- The Hospital of Tropical and Infectious Disease Victor Babes
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Craiova, Roumanie, 200515
- Clinical Infectious Diseases Hospital Victor Babes
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London, Royaume-Uni, E1 1BB
- The Royal London Hospital
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Manchester, Royaume-Uni, M13 9WL
- Manchester Royal Infirmary; Department Of Medicine
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Changhua, Taïwan, 500
- Changhua Christian Hospital; Internal Medicine
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Kaohsiung, Taïwan, 807
- Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
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Kaohsiung, Taïwan, 00833
- Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
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Keelung City, Taïwan, 204
- Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
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Taichung, Taïwan, 404
- China Medical University Hospital; Department of Rheumatology
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Taipei, Taïwan, 112
- Taipei Veterans General Hospital; Gastroenterology Division
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Taipei, Taïwan, 100
- National Taiwan Uni Hospital; Gastro-Enterology Dept.
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Taipei, Taïwan
- Tri-Service Hospital; Dept. of Internal Medicine
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Taoyuan, Taïwan, 333
- Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
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Bangkok, Thaïlande, 10700
- Siriraj Hospital
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Chiang Mai, Thaïlande, 50200
- Chiang Mai Uni Hospital; Faculty of Medicine
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Songkhla, Thaïlande, 90112
- Songklanagarind Hospital; Division of Gastroenterology
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Participants with CHB who received therapy with Peg-IFN ± nucleoside/nucleotide analogue will be included.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: Single blood sample ≥24 weeks post-treatment
|
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.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model
Délai: 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
|
|
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model
Délai: 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
Délai: 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
|
|
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
Délai: Single blood sample ≥24 weeks post-treatment
|
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
|
|
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model
Délai: 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 or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model
Délai: 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 or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model
Délai: 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 Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model
Délai: 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.
|
Single blood sample ≥24 weeks post-treatment
|
|
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model
Délai: 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
Délai: 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.
|
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
Délai: 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
Délai: 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
Délai: 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 HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 août 2013
Achèvement primaire (Réel)
28 novembre 2014
Achèvement de l'étude (Réel)
28 novembre 2014
Dates d'inscription aux études
Première soumission
8 mai 2013
Première soumission répondant aux critères de contrôle qualité
14 mai 2013
Première publication (Estimation)
17 mai 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 avril 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 mars 2017
Dernière vérification
1 mars 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies du foie
- Hépatite, virale, humaine
- Infections à Hépadnaviridae
- Infections par le virus de l'ADN
- Infections à entérovirus
- Infections à Picornaviridae
- Hépatite chronique
- Hépatite B
- Hépatite
- Hépatite A
- Hépatite B chronique
- Agents anti-infectieux
- Agents antiviraux
- Agents antinéoplasiques
- Peginterféron alfa-2a
- Interféron alpha-2
Autres numéros d'identification d'étude
- GV28855
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .