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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT00883844
First received: April 17, 2009
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Chronic Hepatitis B
Drug: Nucleos(t)ide analogue treatment with a peginterferon add-on strategy
Drug: Nucleos(t)ide analogue treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Foundation for Liver Research:

Primary Outcome Measures:
  • Sustained response defined as HBeAg loss and HBV DNA level < 200 IU/mL [ Time Frame: at week 72 ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: April 2009
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Continuation of any Nucleos(t)ide analogue treatment and add-on of peginterferon for 24 weeks
Drug: Nucleos(t)ide analogue treatment with a peginterferon add-on strategy
peginterferon 1.5 microgram/kg once a week Treatment with one of the approved nucleos(t)ide analogues
Active Comparator: 2
Continuation of Nucleos(t)ide analogue mono-therapy
Drug: Nucleos(t)ide analogue treatment
Treatment with one of the approved nucleos(t)ide analogues

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883844

Locations
Netherlands
AMC
Amsterdam, Netherlands
Erasmus MC, University Medical Center Rotterdam
Rotterdam, Netherlands
Sponsors and Collaborators
Foundation for Liver Research
Investigators
Principal Investigator: Harry LA Janssen, MD PhD Erasmus MC, University Medical Center Rotterdam
  More Information

No publications provided

Responsible Party: Foundation for Liver Research
ClinicalTrials.gov Identifier: NCT00883844     History of Changes
Other Study ID Numbers: HBV09-03
Study First Received: April 17, 2009
Last Updated: April 18, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Foundation for Liver Research:
Hepatitis B
sustained response
peginterferon
nucleos(t)ide analogues

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014