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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

8. března 2017 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Aktuální)

1669

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

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

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Lék: 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.
Ostatní jména:
  • Pegasys

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hoffmann-La Roche

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

20. srpna 2013

Primární dokončení (Aktuální)

28. listopadu 2014

Dokončení studie (Aktuální)

28. listopadu 2014

Termíny zápisu do studia

První předloženo

8. května 2013

První předloženo, které splnilo kritéria kontroly kvality

14. května 2013

První zveřejněno (Odhad)

17. května 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. dubna 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. března 2017

Naposledy ověřeno

1. března 2017

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • GV28855

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Hepatitida B, chronická

Klinické studie na Peg-IFN alfa-2a

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Japan

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
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