A Multi-center, Randomized, Open-label study for Induction of HBsAg decline using an add-on treatment of peginterferon alfa-2a in HBeAg-negative chronic hepatitis B patients treated with nucleos(t)ide analogues

Phase 4

Completed

• Conditions: chronic hepatitis B virus infection; 10019654; 10047438

• Registration Number: NL-OMON45209
• Lead Sponsor: Stichting Leveronderzoek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

• Chronic hepatitis B (HBsAg positive > six months)
• HBeAg negative within six months prior to initiation of peginterferon alfa-2a
• (Peg)interferon naïve or experienced patients may both participate
• Treatment with nucleos(t)ide analogues for at least 1 year at screening
• HBV DNA < 200 IU/ml during nucleos(t)ide analogue treatment (except Telbivudine) within one month prior to initiation of peginterferon alfa-2a
• Compensated liver disease
• Age > 18 years
• Adequate contraception
• Written informed consent

Exclusion Criteria

• Treatment with any investigational drug within 30 days of entry to this protocol
• Current treatment with Telbivudine
• 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 *1,500/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. Current methadone usage is allowed.
• 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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome<br /><br>• HBsAg decline > 1 log from baseline at week 48</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes<br /><br>• HBsAg decline > 1 log at weeks 24 and 72<br /><br>• HBsAg decline > 0.5 log at weeks 24 and 48<br /><br>• HBsAg loss at weeks 48 and 72</p><br>