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

Roche

Status and phase: Completed; Phase 3

Conditions: Hepatitis B, Chronic

Treatments: Drug: Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg; Drug: Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg; Drug: Lamivudine (LAM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01095835

ML18253

Details and patient eligibility

About

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.

Enrollment: 131 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 3 patient groups

PEG-IFN48

Experimental group

Description:

Treatment with PEG-IFN in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks.

Treatment:

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

PEG-IFN96

Experimental group

Description:

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).

Treatment:

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

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

PEG-IFN+LAM96

Experimental group

Description:

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).

Treatment:

Drug: Lamivudine (LAM)

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

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