A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B
An Exploratory Evaluation of Interleukin 28B (IL28B) Genotype, Single Nucleotide Polymorphisms (SNP) of rs12356193, Protein and RNA Biomarkers in Serum Samples (Stored, Already Obtained From Completed Studies) From Subjects With HBe-antigen Positive or Negative Chronic Hepatitis B, Who Have Completed Therapy for Hepatitis B With Pegasys ± Lamivudine.
1 other identifier
observational
269
10 countries
27
Brief Summary
This retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis B, who have completed therapy with Pegasys (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from patients will be used; no actual patients are involved.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Shorter than P25 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 9, 2012
CompletedFirst Posted
Study publicly available on registry
October 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedNovember 2, 2016
November 1, 2016
8 months
October 9, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Interleukin-28B (IL-28B) genotype in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine
Samples up to 72 weeks of treatment
Single nucleotide polymorphisms (SNP) of rs12356193 in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine
Samples up to 72 weeks of treatment
Secondary Outcomes (2)
IL-28B concentration at baseline and during treatment with Pegasys +/- lamivudine from stored serum samples of patients with chronic hepatitis B
Samples up to 72 weeks of treatment
Protein/RNA biomarker evaluation from stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine
Samples up to 72 weeks of treatment
Study Arms (1)
Cohort
Eligibility Criteria
Stored serum samples obtained from patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine.
You may qualify if:
- Patients with HBe-antigen positive or negative chronic hepatitis B, and no other chronic viral infections who completed therapy for Hepatitis B with Pegasys ± lamivudine
- Samples from patients treated with either Pegasys or Pegays + lamivudine are included in this analytical study
- Samples will only be analyzed for patients where Investigational Review Board approval has been granted
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Unknown Facility
Herston, Queensland, 4006, Australia
Unknown Facility
Fitzroy, Victoria, 3065, Australia
Unknown Facility
Clichy, 92118, France
Unknown Facility
Hong Kong, 852, Hong Kong
Unknown Facility
Hong Kong, Hong Kong
Unknown Facility
Bari, Apulia, 70124, Italy
Unknown Facility
Brescia, Lombardy, 25123, Italy
Unknown Facility
Cagliari, Sardinia, 09042, Italy
Unknown Facility
Pisa, Tuscany, 56124, Italy
Unknown Facility
Auckland, 100, New Zealand
Unknown Facility
Hamilton, New Zealand
Unknown Facility
Saint Petersburg, 190103, Russia
Unknown Facility
Samara, 443011, Russia
Unknown Facility
Stavropol, 355017, Russia
Unknown Facility
Singapore, 169608, Singapore
Unknown Facility
Singapore, 228510, Singapore
Unknown Facility
Seoul, 03080, South Korea
Unknown Facility
Seoul, 120-752, South Korea
Unknown Facility
Seoul, 138-736, South Korea
Unknown Facility
Kaohsiung City, 807, Taiwan
Unknown Facility
Taipei, 100, Taiwan
Unknown Facility
Taoyuan District, 333, Taiwan
Unknown Facility
Bangkok, 10400, Thailand
Unknown Facility
Bangkok, 10700, Thailand
Unknown Facility
Chiang Mai, 50202, Thailand
Unknown Facility
Khon Kaen, 40002, Thailand
Unknown Facility
Songkhla, 90112, Thailand
Related Publications (1)
van Bommel F, van Bommel A, Krauel A, Wat C, Pavlovic V, Yang L, Deichsel D, Berg T, Bohm S. Serum HBV RNA as a Predictor of Peginterferon Alfa-2a Response in Patients With HBeAg-Positive Chronic Hepatitis B. J Infect Dis. 2018 Aug 24;218(7):1066-1074. doi: 10.1093/infdis/jiy270.
PMID: 29741634DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2012
First Posted
October 12, 2012
Study Start
June 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11