Clinical trial NCT01705704: A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-12
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stored serum samples obtained from patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine.

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.


Eligibility criteria: 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

Exclusion Criteria:

* Exclusion criteria relevant to the clinical studies WV16240, WV16241, and Neptune/WV19432

Primary outcomes:
measure: Interleukin-28B (IL-28B) genotype in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine
timeFrame: Samples up to 72 weeks of treatment
measure: Single nucleotide polymorphisms (SNP) of rs12356193 in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine
timeFrame: Samples up to 72 weeks of treatment
Secondary outcomes:
measure: IL-28B concentration at baseline and during treatment with Pegasys +/- lamivudine from stored serum samples of patients with chronic hepatitis B
timeFrame: Samples up to 72 weeks of treatment
measure: Protein/RNA biomarker evaluation from stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine
timeFrame: Samples up to 72 weeks of treatment
Other outcomes:
Locations:
city: Herston
country: Australia
state: Queensland
city: Fitzroy
country: Australia
state: Victoria
city: Clichy
country: France
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Brescia
country: Italy
state: Lombardia
city: Bari
country: Italy
state: Puglia
city: Cagliari
country: Italy
state: Sardegna
city: Pisa
country: Italy
state: Toscana
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Auckland
country: New Zealand
city: Hamilton
country: New Zealand
city: Samara
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Kaohsiung
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Khon Kaen
country: Thailand
city: Songkhla
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.