Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Alfa-2b Treatment to Increase Sustained Response in HBeAg-positive Chronic Hepatitis B (PEGON-study)
| Registry | NCT01532843, acronym PEGON |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 82 (Actual) |
| Sponsor | Foundation for Liver Research (Other) |
| Conditions | Chronic Hepatitis B |
| Interventions | PegIFN alfa-2b (Drug) |
| Dates | start 2012-06-01, primary completion 2015-08-01, completion 2015-08-01, first posted 2012-02-15, last updated 2019-01-04 |
| Locations | 4 sites in China, Netherlands |
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All trials for Chronic Hepatitis B All trials of PegIFN alfa-2b
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PegIFN alfa-2b + nucleos(t)ide analogue | Active comparator | Drug: PegIFN alfa-2b | Peginterferon alfa-2b 1.5 μg/kg per week s.c. for 48 weeks in addition to standard nucleos(t)ide analogue treatment |
| Nucleos(t)ide analogue | No intervention | Continuation of Nucleos(t)ide analogue mono-therapy |
Sex: All, ages: 18 Years to 70 Years
Inclusion Criteria: * Chronic hepatitis B (HBsAg positive > 6 months) * HBeAg positive, anti-HBe negative within 4 weeks prior to initiation of peginterferon alfa-2b * HBV DNA < 2000 IU/ml within one month prior to initiation of peginterferon alfa-2b after a minimum of 12 months treatment with either Entecavir (one of all 3 brands) or Tenofovir * ALT < 5x ULN * Compensated liver disease * Age ≥ 18 years and ≤ 70 years * Written informed consent Exclusion Criteria: * Treatment with any investigational drug within 30 days of entry to this protocol * Treatment with Telbivudine * Severe hepatitis activity as documented by ALT > 5 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 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
| Facility | City | Country | Status |
|---|---|---|---|
| Ruijin Hospital "Jiaolong University" | Shanghai | China | |
| Public Health Center "Fu Dan University" | Shanghai | China | |
| Zhong Shan Hospital "Fu Dan University" | Shanghai | China | |
| Erasmus MC, University Medical Center | Rotterdam | Netherlands |