A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: Peginterferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT02791269

ML19295

Details and patient eligibility

About

This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48 weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free follow-up period.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-cirrhotic participants
• Hepatitis B surface antigen (HBsAg) positive for at least 6 months
• Hepatitis B surface antibody (anti-HBs) negative
• Elevated serum alanine aminotransferase (ALT) greater than (>) upper limit of normal (ULN) but less than or equal to (</=) 10 times of ULN
• HBeAg positive participants: HBV DNA > 500,000 copies/mL, HBeAg negative participants: HBV DNA >100,000 copies/mL by polymerase chain reaction (PCR)
• Participants with chronic hepatitis B (CHB) who are treatment-naive
• No previous antiviral treatment with interferon (IFN: standard or pegylated) or with a nucleoside analogue
• For women of childbearing potential: negative urine or serum pregnancy test documented within the 24-hour period prior to the first dose of test drug. Willingness to use reliable contraception during the study and for 3 months after treatment completion

Exclusion criteria

• Previous antiviral or IFN-based therapy for CHB before enrolment
• Pregnant or breast feeding women participants
• Evidence of decompensated liver disease
• Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV)
• History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis
• Previous or current hepatocellular carcinoma
• History of or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• Alpha-fetoprotein levels of >100 nanograms (ng)/mL
• Severe psychiatric disease
• History of a severe seizure disorder or current anticonvulsant use
• History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the participant, in the opinion of the investigator, unsuitable for the study
• Thyroid disease uncontrolled by prescribed medications
• Evidence of severe retinopathy
• Alcohol intake more than 3 standard drinks per day for men and 2 standard drinks per day for women

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

HBeAg Negative Participants

Experimental group

Description:

HBeAg negative participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period.

Treatment:

Drug: Peginterferon alfa-2a

HBeAg Positive Participants

Experimental group

Description:

HBeAg Positive participants will receive peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.

Treatment:

Drug: Peginterferon alfa-2a