PEG-IFN in HBV Patients With Incomplete Response to NA

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00883844
• Date of registration: 17/04/2009
• Prospective Registration: No
• Primary sponsor: Foundation for Liver Research
• Public title: PEG-IFN in HBV Patients With Incomplete Response to NA PADD
• Scientific 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
• Date of first enrolment: April 2009
• Target sample size: 11
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00883844
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Netherlands

Contacts

• Name: Harry LA Janssen, MD PhD
• Affiliation: Erasmus MC, University Medical Center Rotterdam

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Hepatitis B

Intervention(s)

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

Drug: Nucleos(t)ide analogue treatment

Primary Outcome(s)

Sustained response defined as HBeAg loss and HBV DNA level < 200 IU/mL [Time Frame: at week 72]

Secondary ID(s)

HBV09-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors