This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg decline \<0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will be a further 48 weeks, during which the participants will continue their NA treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks.
Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.
A.O. Universitaria Ospedali Riuniti Di Foggia; Malattie Infettive
Foggia, Apulia, Italy
Unnamed facility
Foggia, Apulia, Italy
Nuovo Policlinico; Dipartimento di Malattie Infettive
Napoli, Campania, Italy
Unnamed facility
Napoli, Campania, Italy
UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
Bologna, Emilia-Romagna, Italy
Unnamed facility
Bologna, Emilia-Romagna, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Medica
Udine, Friuli Venezia Giulia, Italy
Unnamed facility
Udine, Friuli Venezia Giulia, Italy
Unnamed facility
Rome, Lazio, Italy
Policlinico Umberto I Di Roma
Rome, Lazio, Italy
...and 17 more locations
Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48)
Time frame: Baseline up to Week 48
Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48)
Participants who stopped pegylated interferon (PEG-IFN) treatment during the add-on phase due to serum HBsAg loss and HBsAg seroconversion were considered as responders.
Time frame: Baseline and Week 48
Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96
Change is calculated by HBsAg titer at baseline - HBsAg titer at week of assessments.
Time frame: Baseline, Week 24, 72 and 96
Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48
Time frame: Baseline, Week 48
Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96
HBsAg loss is defined as HBsAg less than or equal to (\</=) 0.05 IU/ml.
Time frame: Week 12 up to Week 96
Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes
Time frame: Baseline and Week 48
Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels
Time frame: Baseline and Week 48
Safety: Percentage of Participants With Adverse Events (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Baseline up to Week 48
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