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Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Treatment to Ncrease Sustained Response in CHB (PEGON)

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
PegIFN alfa-2b
Sponsored by
Foundation for Liver Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Hepatitis B, sustained response, peginterferon, nucleos(t)ide analogues

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ruijin Hospital "Jiaolong University"
  • Public Health Center "Fu Dan University"
  • Zhong Shan Hospital "Fu Dan University"
  • Erasmus MC, University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

PegIFN alfa-2b + nucleos(t)ide analogue

Nucleos(t)ide analogue

Arm Description

Peginterferon alfa-2b 1.5 μg/kg per week s.c. for 48 weeks in addition to standard nucleos(t)ide analogue treatment

Continuation of Nucleos(t)ide analogue mono-therapy

Outcomes

Primary Outcome Measures

Sustained response
Sustained response to therapy, defined as the combined presence of HBeAg seroconversion and HBV DNA < 200 IU/mL

Secondary Outcome Measures

Full Information

First Posted
February 10, 2012
Last Updated
January 3, 2019
Sponsor
Foundation for Liver Research
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1. Study Identification

Unique Protocol Identification Number
NCT01532843
Brief Title
Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Treatment to Ncrease Sustained Response in CHB
Acronym
PEGON
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Liver Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Hepatitis B, sustained response, peginterferon, nucleos(t)ide analogues

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PegIFN alfa-2b + nucleos(t)ide analogue
Arm Type
Active Comparator
Arm Description
Peginterferon alfa-2b 1.5 μg/kg per week s.c. for 48 weeks in addition to standard nucleos(t)ide analogue treatment
Arm Title
Nucleos(t)ide analogue
Arm Type
No Intervention
Arm Description
Continuation of Nucleos(t)ide analogue mono-therapy
Intervention Type
Drug
Intervention Name(s)
PegIFN alfa-2b
Other Intervention Name(s)
Pegintron
Intervention Description
Peginterferon alpha-2b 1.5 μg/kg per week s.c.for 48 weeks
Primary Outcome Measure Information:
Title
Sustained response
Description
Sustained response to therapy, defined as the combined presence of HBeAg seroconversion and HBV DNA < 200 IU/mL
Time Frame
at week 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry LA Janssen, MD PHD
Organizational Affiliation
Erasmus MC, University Medical Center Rotterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital "Jiaolong University"
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Public Health Center "Fu Dan University"
City
Shanghai
ZIP/Postal Code
200083
Country
China
Facility Name
Zhong Shan Hospital "Fu Dan University"
City
Shanghai
ZIP/Postal Code
200083
Country
China
Facility Name
Erasmus MC, University Medical Center
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30689258
Citation
Liem KS, van Campenhout MJH, Xie Q, Brouwer WP, Chi H, Qi X, Chen L, Tabak F, Hansen BE, Janssen HLA. Low hepatitis B surface antigen and HBV DNA levels predict response to the addition of pegylated interferon to entecavir in hepatitis B e antigen positive chronic hepatitis B. Aliment Pharmacol Ther. 2019 Feb;49(4):448-456. doi: 10.1111/apt.15098.
Results Reference
derived
PubMed Identifier
28329061
Citation
Chi H, Hansen BE, Guo S, Zhang NP, Qi X, Chen L, Guo Q, Arends P, Wang JY, Verhey E, de Knegt RJ, Xie Q, Janssen HLA. Pegylated Interferon Alfa-2b Add-on Treatment in Hepatitis B Virus Envelope Antigen-Positive Chronic Hepatitis B Patients Treated with Nucleos(t)ide Analogue: A Randomized, Controlled Trial (PEGON). J Infect Dis. 2017 Apr 1;215(7):1085-1093. doi: 10.1093/infdis/jix024.
Results Reference
derived

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Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Treatment to Ncrease Sustained Response in CHB

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