Chronich hepatitis B virus infection MedDRA version: 14.0 Level: LLT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Pegintron
Product Name: Pegintron
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: PEGINTERFERON ALFA-2B
CAS Number: 215647-85-1
Concentration unit:
Sponsors
Foundation for Liver Research
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate sustained HBeAg response to peg-interferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load;Secondary Objective: no secondary objectives;Primary end point(s): • Sustained response to therapy, defined as the combined presence of HBeAg seroconversion and HBV DNA < 200 IU/mL at week 72;Timepoint(s) of evaluation of this end point: week 72 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Undetectable HBV-DNA (<20 IU/ml) •HBsAg loss from serum •HBsAg decline •HBeAg loss from serum •Combined response defined as the combined presence of HBV DNA level < 200 IU/mL and HBeAg seroconversion at week 48 ;Timepoint(s) of evaluation of this end point: week 48 and 72 | — |
Countries
China, Netherlands
Contacts
Public ContactProject manager
Foundation for Liver research
Outcome results
None listed