Phase 4 N=24 Treatment

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

Hepatitis B, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT02791269 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Feb 2017

Primary outcome: Primary: Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL) — 7 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Peginterferon alfa-2a (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)	7	—
PRIMARY Number of Participants With HBV-DNA <20,000 Copies/mL	0; 3	—
SECONDARY Number of Participants With HBV-DNA <400 Copies/mL	3; 6; 0; 2	—
SECONDARY Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion	0; 0; 0; 0	—
SECONDARY Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level	2; 4; 4; 7	—
SECONDARY Number of Participants With HBeAg Seroconversion	6; 6	—

Summary

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.

Eligibility Criteria

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 ( 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02791269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.