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A Study to Collect Blood Biomarker Samples From Patients With Chronic Hepatitis B Who Received Treatment With Pegasys (Peginterferon Alfa-2a) +/- Nucleos(t)Ide Analogue

This study is currently recruiting participants.
Verified April 2014 by Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 8, 2013
Last updated: April 14, 2014
Last verified: April 2014

This phase 4 study is designed for the collection of blood biomarker samples from patients who have completed chronic hepatitis B treatment with at least 25 weeks of a Pegasys (peginterferon alfa 2a) containing regimen and at least 24 weeks post-treatment follow-up. Patients 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 patients 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 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 patients who previously have consented and donated RCR DNA samples) and medical recor! d capture.

Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Phase 4, 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in HBV DNA (quantitative PCR Test in iU/ml) [ Time Frame: from baseline to end of follow-up ] [ Designated as safety issue: No ]
  • Change in HBsAg/anti-HBs [ Time Frame: from baseline to end of follow-up ] [ Designated as safety issue: No ]
  • Change in HBeAg/anti-HBe [ Time Frame: from baseline to end of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exploratory analysis of association of single nucleotide polymorphisms and treatment responses [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events related to study-specific procedures [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood samples

Estimated Enrollment: 1200
Study Start Date: August 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)


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

Patients with chronic hepatitis B who received therapy with Pegasys +/- nucleos(t)ide analogue


Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic hepatitis B
  • Previously enrolled in a Roche study and treated for CHB for at least 24 weeks with Pegasys +/- nucleoside analogue (lamivudine or entecavir) or Pegasys +/- nucleotide analogue (adefovir) with >/= 24 weeks post-treatment follow-up; or
  • Treated in general practice for CHB with Pegasys according to standard of care and in line with the current Summary of Product Characteristics/local labeling who have non contra-indication to Pegasys therapy as per local label and have been treated with Pegasys for at least 24 weeks and have >/= 24 week post-treatment response available at the time of blood sample collection

Exclusion Criteria:

  • Hepatitis A, hepatitis C or HIV infection
  Contacts and Locations
Please refer to this study by its identifier: NCT01855997

Contact: Reference Study ID Number: GV28855 888-662-6728 (U.S. Only)

  Show 71 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01855997     History of Changes
Other Study ID Numbers: GV28855
Study First Received: May 8, 2013
Last Updated: April 14, 2014
Health Authority: New Zealand: Ministry of Health

Additional relevant MeSH terms:
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
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs processed this record on April 17, 2014