Clinical trial NCT01855997: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-05-17
Enrollment: 1669
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with CHB who received therapy with Peg-IFN ± nucleoside/nucleotide analogue will be included.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: 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
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: 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
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: 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
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant Model
timeFrame: Single blood sample ≥24 weeks post-treatment
Secondary outcomes:
Other outcomes:
measure: Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population
timeFrame: Single blood sample ≥24 weeks post-treatment
measure: Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population
timeFrame: Single blood sample ≥24 weeks post-treatment
Locations:
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
city: Sofia
country: Bulgaria
facility: MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
city: Varna
country: Bulgaria
facility: Mhat Sveta Marina; Clinic of Gastroenterology
city: Beijing
country: China
facility: Beijing Ditan Hospital
city: Beijing
country: China
facility: Beijing 302 Hospital; No. 2 Infectious Disease Section
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing You An Hospital; Digestive Dept
city: Changsha
country: China
facility: Xiangya Hospital of Centre-South University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: The Second Affiliated Hospital, Chongqing Medical University
city: Fu Zhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: The Eighth People's Hospital of Guangzhou
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Hangzhou
country: China
facility: Hangzhou Sixth People's Hospital
city: Harbin
country: China
facility: The 1st Affiliated Hospital of Harbin Medical University
city: Jinan
country: China
facility: Jinan Infectious Diseases Hospital
city: Nanjing
country: China
facility: Nanjing No.2 Hospital; Liver Disease Department
city: Nanning
country: China
facility: The First Affiliate Hospital of Guangxi Medical University
city: Shanghai
country: China
facility: Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
city: Shen Zhen
country: China
facility: Shenzhen Donghu Hospital
city: Shi Jiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
city: Urumqi
country: China
facility: Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine
city: Wuhan
country: China
facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
city: Xi'an
country: China
facility: The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Clichy
country: France
facility: Hopital Beaujon;Hepatologie
city: Creteil
country: France
facility: Hopital Henri Mondor; Hepatologie Gastro Enterologie
city: Rennes
country: France
facility: Hopital de Pontchaillou; Medicine Interne - Hepatologie
city: Saint Laurent Du Var
country: France
facility: Institut Arnault Tzanck; Medecine I Gastro Enterologie
city: Berlin
country: Germany
facility: Praxis Dr. med. Christine John
city: Berlin
country: Germany
facility: Praxis Dr. Heyne
city: Berlin
country: Germany
facility: Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie
city: Hamburg
country: Germany
facility: Ifi- Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
city: Hannover
country: Germany
facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie
city: Athens
country: Greece
facility: Laiko General Hospital Athen; Uni Clinic of Gastrenterology
city: Larissa
country: Greece
facility: University Hospital of Larissa; Pathological Clinic
city: Thessaloniki
country: Greece
facility: Hippokratio Hospital; 4Th Internal Medicine Dpt
city: Caserta
country: Italy
facility: Az. Osp. S. Sebastiano; Divisione Malattie Infettive
state: Campania
city: Napoli
country: Italy
facility: Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia
state: Campania
city: Bologna
country: Italy
facility: UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
state: Emilia-Romagna
city: Parma
country: Italy
facility: Az. Osp. Uni Ria Di Parma; Gastro-Enterology
state: Emilia-Romagna
city: Milano
country: Italy
facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
state: Lombardia
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale
state: Lombardia
city: Bari
country: Italy
facility: Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive
state: Puglia
city: Castellana Grotte
country: Italy
facility: Ospedale de Bellis; Reparto Medicina Generale
state: Puglia
city: Cagliari
country: Italy
facility: Uni Di Cagliari; Dept. Di Scienze Mediche
state: Sardegna
city: Palermo
country: Italy
facility: Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia
state: Sicilia
city: Pisa
country: Italy
facility: Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
state: Toscana
city: Padova
country: Italy
facility: Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.
state: Veneto
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital; Nephrology
city: Chooncheon
country: Korea, Republic of
facility: Chooncheon Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center; Gastroenterology
city: Auckland
country: New Zealand
facility: Auckland Hospital; New Zealand Liver Transplant Unit
city: Bydgoszcz
country: Poland
facility: Hospital For Infectious Diseases; Infectiology
city: Chorzow
country: Poland
facility: Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II; Oddzial Wirusowego Zapalenia Watroby
city: Lancut
country: Poland
facility: Centrum Medyczne
city: Warszawa
country: Poland
facility: Wojewodzki Szpital Zakazny; Klinika Chorob Zakaznych
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA; Oddzial Chorob Wewnetrznych i Hepatologii
city: Zielona Góra
country: Poland
facility: NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby
city: Łodz
country: Poland
facility: Specjalistyczny Szpital Wojewódzki im. Biegańskiego; Klinika Chorób Zakaźnych i Hepatologii UM
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Gastrenterologia e Hepatologia
city: Porto
country: Portugal
facility: Hospital Geral de Santo Antonio; Servico de Gastrenterologia
city: Porto
country: Portugal
facility: Hospital de Sao Joao; Servico de Gastrenterologia
city: Bucharest
country: Romania
facility: Institutul De Boli Infectioase Matei Bals; Sectia Clinica II Boli Infectioase Adulti
city: Bucharest
country: Romania
facility: The Hospital of Tropical and Infectious Disease Victor Babes
city: Craiova
country: Romania
facility: Clinical Infectious Diseases Hospital Victor Babes
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital; Internal Medicine
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
city: Keelung City
country: Taiwan
facility: Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
city: Taichung
country: Taiwan
facility: China Medical University Hospital; Department of Rheumatology
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; Gastro-Enterology Dept.
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital; Gastroenterology Division
city: Taipei
country: Taiwan
facility: Tri-Service Hospital; Dept. of Internal Medicine
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai Uni Hospital; Faculty of Medicine
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital; Division of Gastroenterology
city: London
country: United Kingdom
facility: The Royal London Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary; Department Of Medicine
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Wei L, Pavlovic V, Bansal AT, Chen X, Foster GR, He H, Kao JH, Lampertico P, Liaw YF, Motoc A, Papatheodoridis GV, Piratvisuth T, Plesniak R, Wat C. Genetic variation in FCER1A predicts peginterferon alfa-2a-induced hepatitis B surface antigen clearance in East Asian patients with chronic hepatitis B. J Viral Hepat. 2019 Sep;26(9):1040-1049. doi: 10.1111/jvh.13107. Epub 2019 Jul 23.