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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01855997




Registration number
NCT01855997
Ethics application status
Date submitted
8/05/2013
Date registered
17/05/2013
Date last updated
5/04/2017

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
GV28855
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Peg-IFN alfa-2a

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.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [2] 0 0
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model
Timepoint [2] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [3] 0 0
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model
Timepoint [3] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [4] 0 0
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model
Timepoint [4] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [5] 0 0
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
Timepoint [5] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [6] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model
Timepoint [6] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [7] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model
Timepoint [7] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [8] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model
Timepoint [8] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [9] 0 0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model
Timepoint [9] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [10] 0 0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model
Timepoint [10] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [11] 0 0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model
Timepoint [11] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [12] 0 0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model
Timepoint [12] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [13] 0 0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model
Timepoint [13] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [14] 0 0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model
Timepoint [14] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [15] 0 0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in Non-CN Population: Additive Model
Timepoint [15] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [16] 0 0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in Non-CN Population: Dominant Model
Timepoint [16] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [17] 0 0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in CN Population: Additive Model
Timepoint [17] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [18] 0 0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in CN Population: Dominant Model
Timepoint [18] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [19] 0 0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment: Additive Model
Timepoint [19] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [20] 0 0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment: Dominant Model
Timepoint [20] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [21] 0 0
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
Timepoint [21] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [22] 0 0
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
Timepoint [22] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [23] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in CN Population: Additive Model
Timepoint [23] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [24] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in CN Population: Dominant Model
Timepoint [24] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [25] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment: Additive Model
Timepoint [25] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [26] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment: Dominant Model
Timepoint [26] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [27] 0 0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment in Non-CN Population: Additive Model
Timepoint [27] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [28] 0 0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment in Non-CN Population: Dominant Model
Timepoint [28] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [29] 0 0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment in CN Population: Additive Model
Timepoint [29] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [30] 0 0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment in CN Population: Dominant Model
Timepoint [30] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [31] 0 0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment: Additive Model
Timepoint [31] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [32] 0 0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment: Dominant Model
Timepoint [32] 0 0
Single blood sample =24 weeks post-treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hepatitis A, hepatitis C, or human immunodeficiency virus (HIV) infection

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/11/2014
Sample size
Target
Accrual to date
Final
1669
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Sofia
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Varna
Country [4] 0 0
China
State/province [4] 0 0
Beijing
Country [5] 0 0
China
State/province [5] 0 0
Changsha
Country [6] 0 0
China
State/province [6] 0 0
Chengdu
Country [7] 0 0
China
State/province [7] 0 0
Chongqing
Country [8] 0 0
China
State/province [8] 0 0
Fu Zhou
Country [9] 0 0
China
State/province [9] 0 0
Guangzhou
Country [10] 0 0
China
State/province [10] 0 0
Hangzhou
Country [11] 0 0
China
State/province [11] 0 0
Harbin
Country [12] 0 0
China
State/province [12] 0 0
Jinan
Country [13] 0 0
China
State/province [13] 0 0
Nanjing
Country [14] 0 0
China
State/province [14] 0 0
Nanning
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
China
State/province [16] 0 0
Shen Zhen
Country [17] 0 0
China
State/province [17] 0 0
Shi Jiazhuang
Country [18] 0 0
China
State/province [18] 0 0
Urumqi
Country [19] 0 0
China
State/province [19] 0 0
Wuhan
Country [20] 0 0
China
State/province [20] 0 0
Xi'an
Country [21] 0 0
China
State/province [21] 0 0
Yinchuan
Country [22] 0 0
China
State/province [22] 0 0
Zhengzhou
Country [23] 0 0
France
State/province [23] 0 0
Clichy
Country [24] 0 0
France
State/province [24] 0 0
Creteil
Country [25] 0 0
France
State/province [25] 0 0
Rennes
Country [26] 0 0
France
State/province [26] 0 0
Saint Laurent Du Var
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Hannover
Country [30] 0 0
Greece
State/province [30] 0 0
Athens
Country [31] 0 0
Greece
State/province [31] 0 0
Larissa
Country [32] 0 0
Greece
State/province [32] 0 0
Thessaloniki
Country [33] 0 0
Italy
State/province [33] 0 0
Campania
Country [34] 0 0
Italy
State/province [34] 0 0
Emilia-Romagna
Country [35] 0 0
Italy
State/province [35] 0 0
Lombardia
Country [36] 0 0
Italy
State/province [36] 0 0
Puglia
Country [37] 0 0
Italy
State/province [37] 0 0
Sardegna
Country [38] 0 0
Italy
State/province [38] 0 0
Sicilia
Country [39] 0 0
Italy
State/province [39] 0 0
Toscana
Country [40] 0 0
Italy
State/province [40] 0 0
Veneto
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Busan
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Chooncheon
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul
Country [44] 0 0
New Zealand
State/province [44] 0 0
Auckland
Country [45] 0 0
Poland
State/province [45] 0 0
Bydgoszcz
Country [46] 0 0
Poland
State/province [46] 0 0
Chorzow
Country [47] 0 0
Poland
State/province [47] 0 0
Krakow
Country [48] 0 0
Poland
State/province [48] 0 0
Lancut
Country [49] 0 0
Poland
State/province [49] 0 0
Warszawa
Country [50] 0 0
Poland
State/province [50] 0 0
Zielona Góra
Country [51] 0 0
Poland
State/province [51] 0 0
Lodz
Country [52] 0 0
Portugal
State/province [52] 0 0
Lisboa
Country [53] 0 0
Portugal
State/province [53] 0 0
Porto
Country [54] 0 0
Romania
State/province [54] 0 0
Bucharest
Country [55] 0 0
Romania
State/province [55] 0 0
Craiova
Country [56] 0 0
Taiwan
State/province [56] 0 0
Changhua
Country [57] 0 0
Taiwan
State/province [57] 0 0
Kaohsiung
Country [58] 0 0
Taiwan
State/province [58] 0 0
Keelung City
Country [59] 0 0
Taiwan
State/province [59] 0 0
Taichung
Country [60] 0 0
Taiwan
State/province [60] 0 0
Taipei
Country [61] 0 0
Taiwan
State/province [61] 0 0
Taoyuan
Country [62] 0 0
Thailand
State/province [62] 0 0
Bangkok
Country [63] 0 0
Thailand
State/province [63] 0 0
Chiang Mai
Country [64] 0 0
Thailand
State/province [64] 0 0
Songkhla
Country [65] 0 0
United Kingdom
State/province [65] 0 0
London
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01855997
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01855997