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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01705704




Registration number
NCT01705704
Ethics application status
Date submitted
9/10/2012
Date registered
12/10/2012
Date last updated
2/11/2016

Titles & IDs
Public title
A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B
Scientific title
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.
Secondary ID [1] 0 0
BV28333
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
Cohort -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Interleukin-28B (IL-28B) genotype in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine
Timepoint [1] 0 0
Samples up to 72 weeks of treatment
Primary outcome [2] 0 0
Single nucleotide polymorphisms (SNP) of rs12356193 in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine
Timepoint [2] 0 0
Samples up to 72 weeks of treatment
Secondary outcome [1] 0 0
IL-28B concentration at baseline and during treatment with Pegasys +/- lamivudine from stored serum samples of patients with chronic hepatitis B
Timepoint [1] 0 0
Samples up to 72 weeks of treatment
Secondary outcome [2] 0 0
Protein/RNA biomarker evaluation from stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine
Timepoint [2] 0 0
Samples up to 72 weeks of treatment

Eligibility
Key inclusion criteria
* 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
* Inclusion criteria relevant to the clinical studies WV16240, WV16241, and Neptune/WV19432
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Exclusion criteria relevant to the clinical studies WV16240, WV16241, and Neptune/WV19432

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
269
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
- Herston
Recruitment hospital [2] 0 0
- Fitzroy
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Clichy
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Hong Kong
Country [3] 0 0
Italy
State/province [3] 0 0
Lombardia
Country [4] 0 0
Italy
State/province [4] 0 0
Puglia
Country [5] 0 0
Italy
State/province [5] 0 0
Sardegna
Country [6] 0 0
Italy
State/province [6] 0 0
Toscana
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
New Zealand
State/province [9] 0 0
Hamilton
Country [10] 0 0
Russian Federation
State/province [10] 0 0
Samara
Country [11] 0 0
Russian Federation
State/province [11] 0 0
St Petersburg
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Stavropol
Country [13] 0 0
Singapore
State/province [13] 0 0
Singapore
Country [14] 0 0
Taiwan
State/province [14] 0 0
Kaohsiung
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taipei
Country [16] 0 0
Taiwan
State/province [16] 0 0
Taoyuan
Country [17] 0 0
Thailand
State/province [17] 0 0
Bangkok
Country [18] 0 0
Thailand
State/province [18] 0 0
Chiang Mai
Country [19] 0 0
Thailand
State/province [19] 0 0
Khon Kaen
Country [20] 0 0
Thailand
State/province [20] 0 0
Songkhla

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

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01705704
Trial related presentations / publications
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.
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/NCT01705704