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

Hepatitis B, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855997
• Other study ID #: GV28855
• Status: Completed
• Phase: N/A
• First received: May 8, 2013
• Last updated: December 1, 2015
• Start date: August 2013
• Est. completion date: November 2014

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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 record capture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1398
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Austria,  Bulgaria,  China,  France,  Germany,  Greece,  Italy,  Korea, Republic of,  New Zealand,  Poland,  Portugal,  Romania,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HBV DNA (quantitative PCR Test in iU/ml)		from baseline to end of follow-up	No
Primary	Change in HBsAg/anti-HBs		from baseline to end of follow-up	No
Primary	Change in HBeAg/anti-HBe		from baseline to end of follow-up	No
Secondary	Exploratory analysis of association of single nucleotide polymorphisms and treatment responses		approximately 12 months	No
Secondary	Safety: Incidence of adverse events related to study-specific procedures		approximately 12 months	No