Clinical trial NCT01095835: A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
Official title: A Multicenter, Randomized, Controlled Study Comparing the Efficacy and Safety of 48 Weeks of 40kD Branched Pegylated Interferon Alfa-2a (PEG-IFN, RO 25-8310) Versus 96 Weeks of PEG-IFN, Alone or in Combination With 100 mg Lamivudine for 48 Weeks in Patients With HBeAg-Negative Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-03-30
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a treatment alone and in combination with lamivudine (LAM). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adults 18-70 years of age;
* HBeAg-negative chronic hepatitis B for \>/=6 months;
* liver disease consistent with chronic hepatitis B.

Exclusion Criteria:

* interferon-based, systemic anti-HBV, antiviral, anti-neoplastic, or immunomodulatory therapy \</=12 months before first dose of study drug;
* non-responders to previous interferon therapy;
* co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV);
* hepatocellular cancer;
* compensated (Child A, score 6) or decompensated liver disease (Child B or C).

Primary outcomes:
measure: Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period
timeFrame: At the end of the 48-week follow-up period at Week 144
Secondary outcomes:
measure: Percentage of Participants Achieving the Combined Response at the End of Treatment
timeFrame: At end of treatment at Week 48 or 96 depending on the study arm
measure: Percentage of Participants Achieving the Combined Response at 24 Weeks of Follow-up
timeFrame: At the end of 24 weeks of follow-up at Week 120
measure: Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL
timeFrame: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144
measure: Percentage of Participants Achieving Histological Response
timeFrame: At the end of the 48-week follow-up period at Week 144
measure: Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment
timeFrame: At the end of treatment at Week 48 or 96 depending on the study arm
measure: Percentage of Participants With Lamivudine Genotype Resistance During PEG-IFN+LAM96 Combined Therapy
timeFrame: At the end of the treatment period at Week 96
Other outcomes:
measure: Percentage of Participants With ALT Normalization
timeFrame: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144
measure: Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL
timeFrame: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144
measure: Percentage of Participants With HBV-DNA Below Limit of Quantification
timeFrame: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144
measure: Percentage of Participants With Loss of Hepatitis B Surface Antigen (HbsAg) and Hepatitis B Surface Antibodies (Anti-HBs) Seroconversion
timeFrame: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144
Locations:
city: Caserta
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Parma
country: Italy
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
state: Emilia-Romagna
city: Trieste
country: Italy
state: Friuli-Venezia Giulia
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Brescia
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Torino
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Bari
country: Italy
state: Puglia
city: Castellana Grotte
country: Italy
state: Puglia
city: San Giovanni Rotondo
country: Italy
state: Puglia
city: Cagliari
country: Italy
state: Sardegna
city: Messina
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Pisa
country: Italy
state: Toscana
city: Padova
country: Italy
state: Veneto
city: Verona
country: Italy
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lampertico P, Vigano M, Di Costanzo GG, Sagnelli E, Fasano M, Di Marco V, Boninsegna S, Farci P, Fargion S, Giuberti T, Iannacone C, Regep L, Massetto B, Facchetti F, Colombo M; PegBeLiver Study Group. Randomised study comparing 48 and 96 weeks peginterferon alpha-2a therapy in genotype D HBeAg-negative chronic hepatitis B. Gut. 2013 Feb;62(2):290-8. doi: 10.1136/gutjnl-2011-301430. Epub 2012 Aug 2.