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Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Alfa-2b Treatment to Increase Sustained Response in HBeAg-positive Chronic Hepatitis B (PEGON)

This study is currently recruiting participants.
Verified January 2013 by Foundation for Liver Research
Sponsor:
Information provided by (Responsible Party):
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT01532843
First received: February 10, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes

February 10, 2012
January 3, 2013
June 2012
September 2014   (final data collection date for primary outcome measure)
Sustained response [ Time Frame: at week 72 ] [ Designated as safety issue: No ]
Sustained response to therapy, defined as the combined presence of HBeAg seroconversion and HBV DNA < 200 IU/mL
Same as current
Complete list of historical versions of study NCT01532843 on ClinicalTrials.gov Archive Site
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Not Provided
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Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Alfa-2b Treatment to Increase Sustained Response in HBeAg-positive Chronic Hepatitis B
Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Alfa-2b Treatment to Increase Sustained Response in HBeAg-positive Chronic Hepatitis B (PEGON-study)

Treatment with a nucleoside analogue and subsequent viral decline has shown to partially restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies investigating whether the effect of lowering viral load with nucleoside analogue therapy prior to the initiation of peginterferon results in higher sustained off-treatment responses showed contradictory findings.

The aim of this study is to investigate sustained off-treatment response to peginterferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
Drug: peginterferon alpha-2b
peginterferon alpha-2b 1.5 μg/kg per week s.c.for 48 weeks
Other Name: Pegintron
  • Active Comparator: peginterferon alpha-2b & nucleos(t)ide analogue
    peginterferon alfa-2b 1.5 μg/kg per week s.c. for 48 weeks
    Intervention: Drug: peginterferon alpha-2b
  • No Intervention: Nucleos(t)ide analogue
    Continuation of Nucleos(t)ide analogue mono-therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic hepatitis B (HBsAg positive > 6 months)
  • HBeAg positive, anti-HBe negative within 4 weeks prior to initiation of peginterferon alfa-2b
  • HBV DNA < 2000 IU/ml within one month prior to initiation of peginterferon alfa-2b after a minimum of 12 months treatment with either Entecavir (one of all 3 brands) or Tenofovir
  • ALT < 5x ULN
  • Compensated liver disease
  • Age ≥ 18 years and ≤ 70 years
  • Written informed consent

Exclusion Criteria:

  • Treatment with any investigational drug within 30 days of entry to this protocol
  • Treatment with Telbivudine
  • Severe hepatitis activity as documented by ALT > 5 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 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
  • Hyper- or hypothyroidism (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met)
  • 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
Both
18 Years to 70 Years
No
Contact: Harry LA Janssen, MD PhD +31-10-7035942 M.HOOGENDOORN@ERASMUSMC.NL
Contact: Pauline Arends, MD +31-10-7031618 p.arends@erasmusmc.nl
China,   Netherlands
 
NCT01532843
HBV 11-02
No
Foundation for Liver Research
Foundation for Liver Research
Not Provided
Principal Investigator: Harry LA Janssen, MD PHD Erasmus MC, University Medical Center Rotterdam
Foundation for Liver Research
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP