An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HbeAg-negative Chronic Hepatitis B (Perseas)
Prognostic Factors of Long-term Response to Treatment With Pegylated Interferon Alfa-2a in Patients With HbeAg-negative Chronic Hepatitis B. (Perseas)
1 other identifier
observational
107
1 country
16
Brief Summary
This observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2009
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 24, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedNovember 2, 2016
November 1, 2016
3.5 years
January 24, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with combined (virological and biochemical) response
48 weeks after end of treatment
Secondary Outcomes (2)
Normalization of serum alanine aminotransferase
12 months
Safety (Incidence of adverse events)
12 months
Study Arms (1)
Cohort
Eligibility Criteria
Patients with chronic hepatitis B on treatment with Pegasys
You may qualify if:
- Adult patients, \>/=18 years of age
- Diagnosis of HBeAg-negative chronic hepatitis B with compensated hepatic disease, virus multiplication, raised alanine amino transferase results and/or fibrosis
You may not qualify if:
- Co-infection with hepatitis A, C or D
- Co-infection with human immunodeficiency virus (HIV)
- Severe hepatic dysfunction or decompensated liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
Alexandroupoli, 68100, Greece
Unknown Facility
Athens, 10676, Greece
Unknown Facility
Athens, 115 27, Greece
Unknown Facility
Athens, 11521, Greece
Unknown Facility
Athens, 11527, Greece
Unknown Facility
Athens, 11528, Greece
Unknown Facility
Athens, 124 61, Greece
Unknown Facility
Larissa, 41 110, Greece
Unknown Facility
Pátrai, 265 04, Greece
Unknown Facility
Piraeus, 18454, Greece
Unknown Facility
Piraeus, 18536, Greece
Unknown Facility
Rhodes, 85100, Greece
Unknown Facility
Thessaloniki, 546 42, Greece
Unknown Facility
Thessaloniki, 54636, Greece
Unknown Facility
Thessaloniki, 56429, Greece
Unknown Facility
Thessaloniki, 57010, Greece
Related Publications (1)
Goulis I, Karatapanis S, Akriviadis E, Deutsch M, Dalekos GN, Raptopoulou-Gigi M, Mimidis K, Germanidis G, Drakoulis C, Triantos C, Zintzaras E, Bakalos G, Papatheodoridis G. On-treatment prediction of sustained response to peginterferon alfa-2a for HBeAg-negative chronic hepatitis B patients. Liver Int. 2015 May;35(5):1540-8. doi: 10.1111/liv.12725. Epub 2014 Nov 20.
PMID: 25368957DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2011
First Posted
January 25, 2011
Study Start
May 1, 2009
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11