PEG-IFN in HBV Patients With Incomplete Response to NA

NCT ID: NCT00883844

Last Updated: 2013-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-08-31

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

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Nucleos(t)ide analogue treatment with a peginterferon add-on strategy

Intervention Type: DRUG

peginterferon 1.5 microgram/kg once a week Treatment with one of the approved nucleos(t)ide analogues

2

Continuation of Nucleos(t)ide analogue mono-therapy

Group Type: ACTIVE_COMPARATOR

Nucleos(t)ide analogue treatment

Intervention Type: DRUG

Treatment with one of the approved nucleos(t)ide analogues

Interventions

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

Intervention Type: DRUG

Nucleos(t)ide analogue treatment

Treatment with one of the approved nucleos(t)ide analogues

Intervention Type: DRUG

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Liver Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harry LA Janssen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus MC, University Medical Center Rotterdam

Locations

AMC

Amsterdam, , Netherlands

Erasmus MC, University Medical Center Rotterdam

Rotterdam, , Netherlands

Countries

Netherlands

Other Identifiers

HBV09-03

Identifier Type: -

Identifier Source: org_study_id