Chronic Hepatitis B MedDRA version: 15.0 Level: LLT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: PEGASYS
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGINTERFERON ALFA-2A
CAS Number: 198153-51-4
Current Sponsor code: RO 25-8310
Concentration unit: µg microgram(s)
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults (aged 18-65) with chronic hepatitis B. • Negative for HBeAg. • Infected with HBV genotype D. • In monotherapy with any NA but telbivudine at enrolment, and HBV DNA persistently below 20 IU/ml for at least 12 months. • HBsAg >100 IU/ml at the beginning of the Lead-In phase, confirmed before addition of PEG-IFN. • Showing a steady HBsAg kinetic (HBsAg decrease =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Co-infection with HAV, HCV, HDV, HIV. • Evidence of decompensated liver disease (Child-Pugh =6). • History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures). • Known hypersensitivity to PEG-IFN. • Women with ongoing pregnancy or who are breast feeding. • Neutrophil count 50 mg/ml.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Serum HBsAg decline after 24 weeks of PEG-IFN plus NA combination treatment . 2) Serum HBsAg decline during follow-up, 24 weeks following the end of PEG-IFN plus NA combination treatment 3)Serum HBsAg decline at the end of follow-up, 48 weeks following the end of PEG-IFN plus NA combination treatment. 4) Serum HBsAg loss (HBsAg =0.05 UI/ml) at Study Week 48. 5)Serum HBsAg loss at Study Week 72. 6)Serum HBsAg loss at Study Week 96. 7)Assess the predictive value of IL28B genotype on HBsAg decrease/HBsAg loss. 8)Investigate the relationship between serum levels of IP-10 and HBsAg decrease/HBsAg loss.;Timepoint(s) of evaluation of this end point: 1) Study Week 24 2) Study Week 72 3) Study Week 96 4) study week 48 5) study week 72 6) study week 96 7) and 8) end of the study | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Serum HBsAg decline at the end of PEG-IFN plus NA combination treatment (Study Week 48).;Secondary Objective: - Serum HBsAg decline after 24 weeks of PEG-IFN plus NA combination treatment (Study Week 24). - Serum HBsAg decline during follow-up, 24 weeks following the end of PEG-IFN plus NA combination treatment (Study Week 72). - Serum HBsAg decline at the end of follow-up, 48 weeks following the end of PEG-IFN plus NA combination treatment (Study Week 96). - Serum HBsAg loss (HBsAg =0.05 UI/ml) at Study Week 48. - Serum HBsAg loss at Study Week 72. - Serum HBsAg loss at Study Week 96. - Assess the predictive value of IL28B genotype on HBsAg decrease/HBsAg loss. - Investigate the relationship between serum levels of IP-10 and HBsAg decrease/HBsAg loss. - Safety of the addition of PEG-IFN to the standard treatment with NAs.;Primary end point(s): Serum HBsAg decline at the end of PEG-IFN plus NA combination treatment (Study Week 48).;Timepoint(s) of evaluation of this end point: week 48 | — |
Countries
Italy
Contacts
Public ContactClinical Operations
Roche S.p.A
Outcome results
None listed