Chronic hepatitis B infection MedDRA version: 17.0 Level: PT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Pegasys
Product Name: Peginterferone alfa-2a
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: PEGINTERFERON ALFA-2A
CAS Number: 198153-51-4
Concentrat
Sponsors
Azienda Ospedaliero-Universitaria di Parma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. willingness to participate in the study protocol and to provide informed consent 2. male and female, age between 18 and 70 years 3. HBeAg negative/anti-HBe positive chronic hepatitis B (+/- cirrhosis) proven by histology or non invasive techniques (Fibroscan) before entry 4. if cirrhosis is present, absence of portal hypertension, HCC and ?-FP levels 3.5 gr/dL, bilirubin 1,500 cells/mm3; PLTs >90,000/ mm3 8. Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. Additionally, all fertile male patients with female partners of childbearing age and females must be using two reliable forms of effective contraception (combined) during the study and for 3 months after treatment completion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 72 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Child B or C cirrhosis 2. women who are pregnancy, intent to become pregnant, or who are breast feeding 3. history of severe psychiatric disease, especially depression 4. history of neurological disease, especially epilepsy 5. Addison disease 6. hypertension (PA sis > 170 mmHg; PA dia > 100 mmHg) 7. history or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease 8. ALT = 10xULN 9. positive anti-HDV; positive anti-HCV; positive anti-HIV 10. positive ANA and/or ASMA (> 1/40) 11. antiviral therapy with Interferon in the previous 3 years 12. use of systemic anti-neoplastic or immunomodulatory treatments in the previous 6 months 13. retynopathies 14. tyreopathies 15. history or other evidence of severe illness or any other conditions which would make the patients, in the opinion of investigator, unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether and to what extent 24 weeks of PEG-IFN? therapy can improve HBV-specific T cell responses in HBeAg negative genotype D positive patients with chronic hepatitis B and persistently suppressed viremia induced by NUC therapy;Secondary Objective: Secondary efficacy objectives: •to assess whether during the following 24 weeks of PEG-IFN? therapy HBV-specific T cell responses can be further improved; •to elucidate whether strength and quality of HBV-specific T cell responses are correlated with HBsAg kinetics during PEG-IFN? therapy. Secondary safety objective: •to assess the safety profile of 48 weeks PEG-IFN a2a therapy with nucleoside analogues. ;Primary end point(s): Strength and quality of HBV-specific T cell responses after 24 weeks of PEG-IFN add-on compared to baseline and to the control arm treated with NUC alone.;Timepoint(s) of evaluation of this end point: months 7-13 after the start of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • level of improvement of HBV-specific T cell responses after additional 24 weeks of PEG-IFN therapy (48 weeks total) compared to the 24 weeks data; • mean change in serum HBsAg at week 48 of PEG-IFN add-on compared to baseline and to the control arm treated with NUC alone; • level of correlation between decline in serum HBsAg and improvement of HBV-specific T cell responses; • changes in Treg and NK cell activity after 24 and 48 weeks of PEG-IFN add-on compared to baseline and to the control arm treated with NUC alone. ;Timepoint(s) of evaluation of this end point: months 13-25 after the start of the study | — |
Countries
Italy
Contacts
Public ContactSegreteria Comitato Etico per Parma
Azienda Ospedaliero-Universitaria di Parma
Outcome results
None listed