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COMPLETEDPHASE3

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

NCT01095835•Hoffmann-La Roche

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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).

Locations (22)

Bari, Apulia, Italy

Castellana Grotte, Apulia, Italy

San Giovanni Rotondo, Apulia, Italy

Caserta, Campania, Italy

Naples, Campania, Italy

Bologna, Emilia-Romagna, Italy

Parma, Emilia-Romagna, Italy

Reggio Emilia, Emilia-Romagna, Italy

Trieste, Friuli Venezia Giulia, Italy

Key Dates

Start Date

February 1, 2005

Primary Completion Date

January 1, 2010

Completion Date

January 1, 2010

Last Updated

November 3, 2016

Enrollment

131

ACTUAL participants

Conditions

Hepatitis B, Chronic

Interventions

Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg

DRUG

Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg

DRUG

Lamivudine (LAM)

DRUG

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

NCT04166266

Hepatitis D, ChronicHepatitis B, Chronic

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RECRUITING

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

NCT06550622

Hepatitis B, Chronic

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RECRUITINGEARLY_PHASE1

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)

Inclusion Criteria

Exclusion Criteria

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels