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PEG-IFN in HBV Patients With Incomplete Response to NA (PADD)

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Nucleos(t)ide analogue treatment with a peginterferon add-on strategy
Nucleos(t)ide analogue treatment
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 - 65 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 one month prior to initiation of peginterferon alfa-2b
  • HBV DNA < 2000 IU/ml during nucleos(t)ide analogue treatment within one month prior to initiation of peginterferon alfa-2b
  • Compensated liver disease
  • Age > 18 years
  • Written informed consent

Exclusion Criteria:

  • Treatment with any investigational drug within 30 days of entry to this protocol
  • 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 <1,800/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
  • 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

  • AMC
  • Erasmus MC, University Medical Center Rotterdam

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Continuation of any Nucleos(t)ide analogue treatment and add-on of peginterferon for 24 weeks

Continuation of Nucleos(t)ide analogue mono-therapy

Outcomes

Primary Outcome Measures

Sustained response defined as HBeAg loss and HBV DNA level < 200 IU/mL

Secondary Outcome Measures

Full Information

First Posted
April 17, 2009
Last Updated
April 18, 2013
Sponsor
Foundation for Liver Research
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1. Study Identification

Unique Protocol Identification Number
NCT00883844
Brief Title
PEG-IFN in HBV Patients With Incomplete Response to NA
Acronym
PADD
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 - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (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
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Continuation of any Nucleos(t)ide analogue treatment and add-on of peginterferon for 24 weeks
Arm Title
2
Arm Type
Active Comparator
Arm Description
Continuation of Nucleos(t)ide analogue mono-therapy
Intervention Type
Drug
Intervention Name(s)
Nucleos(t)ide analogue treatment with a peginterferon add-on strategy
Intervention Description
peginterferon 1.5 microgram/kg once a week Treatment with one of the approved nucleos(t)ide analogues
Intervention Type
Drug
Intervention Name(s)
Nucleos(t)ide analogue treatment
Intervention Description
Treatment with one of the approved nucleos(t)ide analogues
Primary Outcome Measure Information:
Title
Sustained response defined as HBeAg loss and HBV DNA level < 200 IU/mL
Time Frame
at week 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic hepatitis B (HBsAg positive > 6 months) HBeAg positive, anti-HBe negative within one month prior to initiation of peginterferon alfa-2b HBV DNA < 2000 IU/ml during nucleos(t)ide analogue treatment within one month prior to initiation of peginterferon alfa-2b Compensated liver disease Age > 18 years Written informed consent Exclusion Criteria: Treatment with any investigational drug within 30 days of entry to this protocol 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 <1,800/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 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
AMC
City
Amsterdam
Country
Netherlands
Facility Name
Erasmus MC, University Medical Center Rotterdam
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

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PEG-IFN in HBV Patients With Incomplete Response to NA

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