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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

2017年3月8日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

1669

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100044
        • Peking University People's Hospital
      • Beijing、中国、100011
        • Beijing Ditan Hospital
      • Beijing、中国、100039
        • Beijing 302 Hospital; No. 2 Infectious Disease Section
      • Beijing、中国、100069
        • Beijing You An Hospital; Digestive Dept
      • Changsha、中国、410008
        • Xiangya Hospital of Centre-South University
      • Chengdu、中国、610041
        • West China Hospital, Sichuan University
      • Chongqing、中国、400010
        • The Second Affiliated Hospital, Chongqing Medical University
      • Fu Zhou、中国、350005
        • The First Affiliated Hospital of Fujian Medical University
      • Guangzhou、中国
        • Guangdong General Hospital
      • Guangzhou、中国、510515
        • Nanfang Hospital, Southern Medical University
      • Guangzhou、中国、510060
        • The Eighth People's Hospital of Guangzhou
      • Hangzhou、中国
        • Hangzhou Sixth People's Hospital
      • Harbin、中国、150001
        • The 1st Affiliated Hospital of Harbin Medical University
      • Jinan、中国、250021
        • JiNan Infectious Diseases Hospital
      • Nanjing、中国、210003
        • Nanjing No.2 Hospital; Liver Disease Department
      • Nanning、中国、530021
        • The First Affiliate Hospital of Guangxi Medical University
      • Shanghai、中国、201508
        • Shanghai Public Health Clinical Center
      • Shanghai、中国、200021
        • Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
      • Shen Zhen、中国、518020
        • Shenzhen Donghu Hospital
      • Shi Jiazhuang、中国、050051
        • The Third Hospital of Hebei Medical University
      • Urumqi、中国、830001
        • Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
      • Wuhan、中国、430030
        • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
      • Xi'an、中国、710038
        • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
      • Yinchuan、中国、750004
        • General Hospital of Ningxia Medical University
      • Zhengzhou、中国、450003
        • Henan Provincial People's Hospital
  • 保加利亚
      • Sofia、保加利亚、1407
        • MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
      • Varna、保加利亚、9010
        • Mhat Sveta Marina; Clinic of Gastroenterology
  • 台湾
      • Changhua、台湾、500
        • Changhua Christian Hospital; Internal Medicine
      • Kaohsiung、台湾、807
        • Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
      • Kaohsiung、台湾、00833
        • Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
      • Keelung City、台湾、204
        • Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
      • Taichung、台湾、404
        • China Medical University Hospital; Department of Rheumatology
      • Taipei、台湾、112
        • Taipei Veterans General Hospital; Gastroenterology Division
      • Taipei、台湾、100
        • National Taiwan Uni Hospital; Gastro-Enterology Dept.
      • Taipei、台湾
        • Tri-Service Hospital; Dept. of Internal Medicine
      • Taoyuan、台湾、333
        • Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
  • 大韩民国
      • Busan、大韩民国、633-165
        • Inje University Busan Paik Hospital; Nephrology
      • Chooncheon、大韩民国、200-060
        • Chooncheon Sacred Heart Hospital
      • Seoul、大韩民国、135-710
        • Samsung Medical Center; Gastroenterology
  • 奥地利
      • Wien、奥地利、1090
        • Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
  • 希腊
      • Athens、希腊、115 27
        • Laiko General Hospital Athen; Uni Clinic of Gastrenterology
      • Larissa、希腊、41 110
        • University Hospital of Larissa; Pathological Clinic
      • Thessaloniki、希腊、546 42
        • Hippokratio Hospital; 4Th Internal Medicine Dpt
  • 德国
      • Berlin、德国、13353
        • Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie
      • Berlin、德国、10117
        • Praxis Dr. med. Christine John
      • Berlin、德国、10969
        • Praxis Dr. Heyne
      • Hamburg、德国、20099
        • Ifi- Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
      • Hannover、德国、30625
        • Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie
  • 意大利
    • Campania
      • Caserta、Campania、意大利、81100
        • Az. Osp. S. Sebastiano; Divisione Malattie Infettive
      • Napoli、Campania、意大利、80131
        • Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia
    • Emilia-Romagna
      • Bologna、Emilia-Romagna、意大利、40138
        • UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
      • Parma、Emilia-Romagna、意大利、43100
        • Az. Osp. Uni Ria Di Parma; Gastro-Enterology
    • Lombardia
      • Milano、Lombardia、意大利、20122
        • Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
      • Milano、Lombardia、意大利、20122
        • Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale
    • Puglia
      • Bari、Puglia、意大利、70124
        • Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive
      • Castellana Grotte、Puglia、意大利、70013
        • Ospedale de Bellis; Reparto Medicina Generale
    • Sardegna
      • Cagliari、Sardegna、意大利、09042
        • Uni Di Cagliari; Dept. Di Scienze Mediche
    • Sicilia
      • Palermo、Sicilia、意大利、90127
        • Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia
    • Toscana
      • Pisa、Toscana、意大利、56124
        • Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
    • Veneto
      • Padova、Veneto、意大利、35128
        • Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.
  • 新西兰
      • Auckland、新西兰、100
        • Auckland Hospital; New Zealand Liver Transplant Unit
  • 法国
      • Clichy、法国、92118
        • Hopital Beaujon;Hepatologie
      • Creteil、法国、94010
        • Hopital Henri Mondor; Hepatologie Gastro Enterologie
      • Rennes、法国、35033
        • Hopital de Pontchaillou; Medicine Interne - Hepatologie
      • Saint Laurent Du Var、法国、06721
        • Institut Arnault Tzanck; Medecine I Gastro Enterologie
  • 波兰
      • Bydgoszcz、波兰、85-030
        • Hospital For Infectious Diseases; Infectiology
      • Chorzow、波兰、41-500
        • Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny
      • Krakow、波兰、31-202
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II; Oddzial Wirusowego Zapalenia Watroby
      • Lancut、波兰、37-100
        • Centrum Medyczne
      • Warszawa、波兰、02-507
        • Centralny Szpital Kliniczny MSWiA; Oddzial Chorob Wewnetrznych i Hepatologii
      • Warszawa、波兰、01-201
        • Wojewodzki Szpital Zakazny; Klinika Chorob Zakaznych
      • Zielona Góra、波兰、65-044
        • NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby
      • Łodz、波兰、91-347
        • Specjalistyczny Szpital Wojewódzki im. Biegańskiego; Klinika Chorób Zakaźnych i Hepatologii UM
  • 泰国
      • Bangkok、泰国、10700
        • Siriraj Hospital
      • Chiang Mai、泰国、50200
        • Chiang Mai Uni Hospital; Faculty of Medicine
      • Songkhla、泰国、90112
        • Songklanagarind Hospital; Division of Gastroenterology
  • 罗马尼亚
      • Bucharest、罗马尼亚、021105
        • Institutul De Boli Infectioase Matei Bals; Sectia Clinica II Boli Infectioase Adulti
      • Bucharest、罗马尼亚、030303
        • The Hospital of Tropical and Infectious Disease Victor Babes
      • Craiova、罗马尼亚、200515
        • Clinical Infectious Diseases Hospital Victor Babes
  • 英国
      • London、英国、E1 1BB
        • The Royal London Hospital
      • Manchester、英国、M13 9WL
        • Manchester Royal Infirmary; Department Of Medicine
  • 葡萄牙
      • Lisboa、葡萄牙、1649-035
        • Hospital de Santa Maria; Servico de Gastrenterologia e Hepatologia
      • Porto、葡萄牙、4099-001
        • Hospital Geral de Santo Antonio; Servico de Gastrenterologia
      • Porto、葡萄牙、4202-451
        • Hospital de Sao Joao; Servico de Gastrenterologia

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Participants with CHB who received therapy with Peg-IFN ± nucleoside/nucleotide analogue will be included.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
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.
药品：Peg-IFN alfa-2a
Participants received Peg-IFN alfa-2a prior to enrollment for at least 24 weeks. Dosing was chosen according to standard of care or at the discretion of the treating physician.
其他名称：
  • 飞马座

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hoffmann-La Roche

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年8月20日

初级完成 (实际的)

2014年11月28日

研究完成 (实际的)

2014年11月28日

研究注册日期

首次提交

2013年5月8日

首先提交符合 QC 标准的

2013年5月14日

首次发布 (估计)

2013年5月17日

研究记录更新

最后更新发布 (实际的)

2017年4月5日

上次提交的符合 QC 标准的更新

2017年3月8日

最后验证

2017年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GV28855

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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