A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: Peginterferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT02604823

ML17700

Details and patient eligibility

About

This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 307 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants between 18 to 65 years of age
• HBeAg-positive chronic HBV
• Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.

Exclusion criteria

• Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment
• Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV)
• Evidence of decompensated liver disease
• Medical condition associated with chronic liver disease other than viral hepatitis.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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307 participants in 3 patient groups

Group A (Naïve Participants)

Experimental group

Description:

Participants who never received any HBV treatment, will receive peginterferon alfa-2a (180 micrograms \[mcg\]) subcutaneously once weekly for 48 weeks.

Treatment:

Drug: Peginterferon alfa-2a

Group B (Conventional Interferon Pretreated Participants)

Experimental group

Description:

Participants who received conventional interferon treatment and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.

Treatment:

Drug: Peginterferon alfa-2a

Group C (Lamivudine Pretreated Participants)

Experimental group

Description:

Participants who received lamivudine and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.

Treatment:

Drug: Peginterferon alfa-2a