Status:
COMPLETED
A Study to Collect Blood Biomarker Samples From Participants With Chronic Hepatitis B (CHB) Who Received Treatment With Pegasys (Peginterferon Alfa-2a) ± Nucleoside/Nucleotide Analogue
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
This Phase 4 study is designed for the collection of blood biomarker samples from participants who have completed CHB treatment with at least 24 weeks of a pegylated interferon alfa-2a (Peg-IFN alfa-2...
Eligibility Criteria
Inclusion
- Adults greater than or equal to (≥) 18 years of age
- CHB
- Previously enrolled in a Roche study and treated for CHB for ≥24 weeks with Peg-IFN ± nucleoside analogue (lamivudine or entecavir) or Peg-IFN ± nucleotide analogue (adefovir) and with ≥24 weeks post-treatment follow-up; or
- Treated in general practice for CHB with Peg-IFN according to standard of care and in line with the current Summary of Product Characteristics (SmPC)/local labeling who have no contraindication to Peg-IFN therapy as per local label and have been treated with Peg-IFN for ≥24 weeks and have ≥24 week post-treatment response available at the time of blood sample collection
Exclusion
- Hepatitis A, hepatitis C, or human immunodeficiency virus (HIV) infection
Key Trial Info
Start Date :
August 20 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 28 2014
Estimated Enrollment :
1669 Patients enrolled
Trial Details
Trial ID
NCT01855997
Start Date
August 20 2013
End Date
November 28 2014
Last Update
April 5 2017
Active Locations (84)
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1
Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
Vienna, Austria, 1090
2
MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
Sofia, Bulgaria, 1407
3
Mhat Sveta Marina; Clinic of Gastroenterology
Varna, Bulgaria, 9010
4
Beijing Ditan Hospital
Beijing, China, 100011