PEG-IFN in HBV Patients With Incomplete Response to NA

NCT00883844 | Completed Phase 4

• 1 other identifier: HBV09-03
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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

Keywords

Hepatitis B; sustained response; peginterferon; nucleos(t)ide analogues

Outcome Measures

Primary Outcomes (1)

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

  at week 72

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

Continuation of Nucleos(t)ide analogue mono-therapy

Drug: Nucleos(t)ide analogue treatment

Interventions

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

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

1

Nucleos(t)ide analogue treatment DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation for Liver Research: lead

Study Sites (2)

AMC

Amsterdam, Netherlands

Location

Erasmus MC, University Medical Center Rotterdam

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Harry LA Janssen, MD PhD

  Erasmus MC, University Medical Center Rotterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 19, 2013

Record last verified: 2013-04

Locations

NL (2)