Trial record 124 of 435 for:    hepatitis b | Open Studies

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. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01855997
First received: May 8, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

This phase 4 study is designed for the collection of blood biomarker samples fro m patients who have completed chronic hepatitis B treatment with at least 25 wee ks of a Pegasys (peginterferon alfa 2a) containing regimen and at least 24 weeks post-treatment follow-up. Patients may be enrolled from historical studies supp orted or sponsored by Roche, ongoing studies supported or sponsored by Roche or from general medical practice. The follow-up of patients who choose to participa te in this study will be in accordance with the ongoing studies or with the gene ral medical practice of the physician. Data from whole blood DNA samples collect ed in the GV28555 study or available from previously collected Roche Clinical Re pository (RCR) samples will be used for combined analysis with data from other a pplicable studies. Procedures will include blood sample collection (not applicab le for patients who previously have consented and donated RCR DNA samples) and m edical record capture.


Condition
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: February 2015
Estimated Primary Completion Date: February 2015 (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

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855997

Contacts
Contact: Reference Study ID Number: GV28855 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 86 Study Locations
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: NCT01855997     History of Changes
Other Study ID Numbers: GV28855
Study First Received: May 8, 2013
Last Updated: August 11, 2014
Health Authority: New Zealand: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
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
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014