Trial record 10 of 444 for:    hepatitis b | Open Studies

A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B

This study is currently recruiting participants.
Verified October 2012 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01705704
First received: October 9, 2012
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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.


Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Interleukin-28B (IL-28B) genotype in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine [ Time Frame: Samples up to 72 weeks of treatment ] [ Designated as safety issue: No ]
  • Single nucleotide polymorphisms (SNP) of rs12356193 in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine [ Time Frame: Samples up to 72 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IL-28B concentration at baseline and during treatment with Pegasys +/- lamivudine from stored serum samples of patients with chronic hepatitis B [ Time Frame: Samples up to 72 weeks of treatment ] [ Designated as safety issue: No ]
  • Protein/RNA biomarker evaluation from stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine [ Time Frame: Samples up to 72 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 1300
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Stored serum samples obtained from patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01705704

Contacts
Contact: Please reference Study ID Number: BV28333 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Russian Federation
Recruiting
Samara, Russian Federation, 443011
Recruiting
St Petersburg, Russian Federation, 190103
Recruiting
Stavropol, Russian Federation, 355017
Thailand
Recruiting
Bangkok, Thailand, 10700
Recruiting
Bangkok, Thailand, 10400
Recruiting
Chiang Mai, Thailand, 50202
Recruiting
Khon Kaen, Thailand, 40002
Recruiting
Songkhla, Thailand, 90112
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01705704     History of Changes
Other Study ID Numbers: BV28333
Study First Received: October 9, 2012
Last Updated: October 10, 2012
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on April 14, 2014