PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients
PAS
Induction of HBsAg Decline Using an add-on Treatment of Peginterferon Alfa-2a in HBeAg-negative Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogous (PAS)
1 other identifier
interventional
90
2 countries
8
Brief Summary
This study intends to investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative chronic hepatitis B patients who are pretreated with nucleos(t)ide analogues enhances the degree of HBsAg decline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2012
Longer than P75 for phase_4
8 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
First Submitted
Initial submission to the registry
June 14, 2011
CompletedFirst Posted
Study publicly available on registry
June 15, 2011
CompletedStudy Start
First participant enrolled
May 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2019
CompletedNovember 8, 2019
November 1, 2019
7.4 years
June 14, 2011
November 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HBsAg decline
HBsAg decline \> 1 log from baseline at week 48
week 48
Secondary Outcomes (3)
HBsAg decline
week 24 and 72
HBsAg decline
week 24 and 48
HBsAg loss
week 48 and 72
Study Arms (2)
Peginterferon alfa-2a add on
EXPERIMENTALAll patients are all currently being treated with long-term NA treatment. PEG-IFN will be given in a dose of 180 μg per week s.c. for a total duration of 48 weeks starting at week 0.
Nucleoside analogue
ACTIVE COMPARATORAll patients are all currently being treated with long-term Nucleos(t)ide analogue treatment and will continue using this medication during the duration of the study.
Interventions
180 μg per week s.c. for a total duration of 48 weeks.
All patients are all currently being treated with long-term NA treatment and will continue using these during the study. Dosage depends on which Nucleos(t)ide analogue they are using.
Eligibility Criteria
You may qualify if:
- Chronic hepatitis B (HBsAg positive \> 6 months)
- HBeAg negative within six months prior to initiation of peginterferon alfa-2a
- HBV DNA \< 200 IU/ml during nucleos(t)ide analogue (except Telbivudine) treatment within one month prior to initiation of peginterferon alfa-2a
- Compensated liver disease
- Age \> 18 years
- Written informed consent
You may not qualify if:
- Treatment with any investigational drug within 30 days of entry to this protocol
- Current treatment with Telbivudine
- Severe hepatitis activity as documented by ALT\>10 x ULN
- History of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy)
- Pre-existent neutropenia (neutrophils \<1,500/mm3) or thrombocytopenia (platelets \< 90,000/mm3)
- Co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus (HIV)
- Other acquired or inherited causes of liver disease: alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency
- Alpha fetoprotein \> 50 ng/ml
- Immune suppressive treatment within the previous 6 months
- Contra-indications for alfa-interferon therapy like suspected hypersensitivity to interferon or Peginterferon or any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study.
- Pregnancy, breast-feeding
- Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant)
- Any medical condition requiring, or likely to require chronic systemic administration of steroids, during the course of the study
- Substance abuse, such as alcohol (\>80 g/day), I.V. drugs and inhaled drugs in the past 2 years.
- Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Foundation for Liver Researchlead
- Hoffmann-La Rochecollaborator
Study Sites (8)
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Erasmus Medical Center
Rotterdam, South Holland, 3015 CE, Netherlands
Onze Lieve Vrouwen Gasthuis
Amsterdam, Netherlands
VU university medical center
Amsterdam, Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Reinier de Graaf Gasthuis
Delft, Netherlands
Spaarne Gasthuis
Haarlem, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
H.L.A. Janssen, MD PhD
Erasmus Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2011
First Posted
June 15, 2011
Study Start
May 25, 2012
Primary Completion
October 28, 2019
Study Completion
October 28, 2019
Last Updated
November 8, 2019
Record last verified: 2019-11