PEG-IFN in HBV Patients With Incomplete Response to NA

Phase 4

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Nucleos(t)ide analogue treatment with a peginterferon add-on strategy; Drug: Nucleos(t)ide analogue treatment

• Registration Number: NCT00883844
• Lead Sponsor: Foundation for Liver Research

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Primary Completion: 2012-06
• Study Completion: 2012-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nucleos(t)ide analogue treatment with a peginterferon add-on strategy	Continuation of any Nucleos(t)ide analogue treatment and add-on of peginterferon for 24 weeks
2	Nucleos(t)ide analogue treatment	Continuation of Nucleos(t)ide analogue mono-therapy

Primary Outcome Measures

Name	Time	Method
Sustained response defined as HBeAg loss and HBV DNA level < 200 IU/mL	at week 72

Trial Locations

Locations (2)

AMC; 🇳🇱 Amsterdam, Netherlands

Erasmus MC, University Medical Center Rotterdam; 🇳🇱 Rotterdam, Netherlands