A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative 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

NCT02570191

ML18092

Details and patient eligibility

About

This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants 18-70 years of age
• Positive test result for HBsAg for >6 months
• Naive to treatment for HBV
• On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis

Exclusion criteria

• Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)
• Decompensated liver disease
• Hepatocellular cancer
• Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug
• Medical condition associated with chronic liver disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Peginterferon alfa-2a

Experimental group

Description:

Participants received 180 micrograms (uG) of Pegasys (0.5 milliliter \[mL\] solution) once a week subcutaneously for 48 weeks.

Treatment:

Drug: Peginterferon alfa-2a