A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
NCT ID: NCT01095835
Last Updated: 2016-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
131 participants
INTERVENTIONAL
2005-02-28
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PEG-IFN48
Treatment with PEG-IFN in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks.
Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg
PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
PEG-IFN96
Treatment 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).
Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg
PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg
PEG-IFN alfa-2a 135 mcg was administered subcutaneously, once weekly from Week 49 to 96.
PEG-IFN+LAM96
Treatment 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).
Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg
PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg
PEG-IFN alfa-2a 135 mcg was administered subcutaneously, once weekly from Week 49 to 96.
Lamivudine (LAM)
Lamivudine 100 milligrams (mg) was administered orally, daily from Week 0 to 48.
Interventions
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Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg
PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg
PEG-IFN alfa-2a 135 mcg was administered subcutaneously, once weekly from Week 49 to 96.
Lamivudine (LAM)
Lamivudine 100 milligrams (mg) was administered orally, daily from Week 0 to 48.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HBeAg-negative chronic hepatitis B for \>/=6 months;
* liver disease consistent with chronic hepatitis B.
Exclusion Criteria
* 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).
18 Years
70 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Bari, Apulia, Italy
Castellana Grotte, Apulia, Italy
San Giovanni Rotondo, Apulia, Italy
Caserta, Campania, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Bologna, Emilia-Romagna, Italy
Parma, Emilia-Romagna, Italy
Reggio Emilia, Emilia-Romagna, Italy
Trieste, Friuli Venezia Giulia, Italy
Udine, Friuli Venezia Giulia, Italy
Brescia, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Turin, Piedmont, Italy
Turin, Piedmont, Italy
Cagliari, Sardinia, Italy
Messina, Sicily, Italy
Palermo, Sicily, Italy
Pisa, Tuscany, Italy
Padua, Veneto, Italy
Verona, Veneto, Italy
Countries
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References
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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.
Other Identifiers
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ML18253
Identifier Type: -
Identifier Source: org_study_id