A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
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
1 other identifier
interventional
131
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2005
Longer than P75 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 26, 2010
CompletedFirst Posted
Study publicly available on registry
March 30, 2010
CompletedResults Posted
Study results publicly available
November 3, 2016
CompletedNovember 3, 2016
March 1, 2016
4.9 years
March 26, 2010
September 15, 2016
September 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period
Combined response was defined as alanine aminotransferase (ALT) normalization plus lowering of hepatitis B virus (HBV) deoxyribo nucleic acid (DNA) levels to \<20,000 copies/mL (\<3,400 IU/mL) and was measured at the end of the 48-week follow-up period. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.
At the end of the 48-week follow-up period at Week 144
Secondary Outcomes (6)
Percentage of Participants Achieving the Combined Response at the End of Treatment
At end of treatment at Week 48 or 96 depending on the study arm
Percentage of Participants Achieving the Combined Response at 24 Weeks of Follow-up
At the end of 24 weeks of follow-up at Week 120
Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL
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
Percentage of Participants Achieving Histological Response
At the end of the 48-week follow-up period at Week 144
Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment
At the end of treatment at Week 48 or 96 depending on the study arm
- +1 more secondary outcomes
Other Outcomes (4)
Percentage of Participants With ALT Normalization
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
Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL
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
Percentage of Participants With HBV-DNA Below Limit of Quantification
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
- +1 more other outcomes
Study Arms (3)
PEG-IFN48
EXPERIMENTALTreatment with PEG-IFN in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks.
PEG-IFN96
EXPERIMENTALTreatment with PEG-IFN in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN treatment (total 96 weeks of treatment).
PEG-IFN+LAM96
EXPERIMENTALTreatment with PEG-IFN and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN treatment (total 96 weeks of treatment).
Interventions
PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
PEG-IFN alfa-2a 135 mcg was administered subcutaneously, once weekly from Week 49 to 96.
Lamivudine 100 milligrams (mg) was administered orally, daily from Week 0 to 48.
Eligibility Criteria
You may qualify if:
- adults 18-70 years of age;
- HBeAg-negative chronic hepatitis B for \>/=6 months;
- liver disease consistent with chronic hepatitis B.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Bari, Apulia, 70124, Italy
Unknown Facility
Castellana Grotte, Apulia, 70013, Italy
Unknown Facility
San Giovanni Rotondo, Apulia, 71013, Italy
Unknown Facility
Caserta, Campania, 81100, Italy
Unknown Facility
Napoli, Campania, 80131, Italy
Unknown Facility
Napoli, Campania, 80135, Italy
Unknown Facility
Bologna, Emilia-Romagna, 40138, Italy
Unknown Facility
Parma, Emilia-Romagna, 43100, Italy
Unknown Facility
Reggio Emilia, Emilia-Romagna, 42100, Italy
Unknown Facility
Trieste, Friuli Venezia Giulia, 34100, Italy
Unknown Facility
Udine, Friuli Venezia Giulia, 33100, Italy
Unknown Facility
Brescia, Lombardy, 25125, Italy
Unknown Facility
Milan, Lombardy, 20121, Italy
Unknown Facility
Milan, Lombardy, 20122, Italy
Unknown Facility
Turin, Piedmont, 10126, Italy
Unknown Facility
Turin, Piedmont, 10149, Italy
Unknown Facility
Cagliari, Sardinia, 09042, Italy
Unknown Facility
Messina, Sicily, 98124, Italy
Unknown Facility
Palermo, Sicily, 90127, Italy
Unknown Facility
Pisa, Tuscany, 56124, Italy
Unknown Facility
Padua, Veneto, 35128, Italy
Unknown Facility
Verona, Veneto, 37134, Italy
Related Publications (1)
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.
PMID: 22859496DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2010
First Posted
March 30, 2010
Study Start
February 1, 2005
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
November 3, 2016
Results First Posted
November 3, 2016
Record last verified: 2016-03