A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253

Hoffmann-La Roche88 enrolled

Overview

This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the predecessor ML18253 study. The study consists of a single visit where eligible patients will undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hepatitis B, Chronic

Interventions

Interleukin 28B testingOTHER

Blood sampling for IL28B genotyping

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Chronic hepatitis B * Previous participation in study ML18253 * Administration of at least one dose of the study drug during ML18253 study Exclusion Criteria: * Patients not satisfying the above inclusion criteria will not be enrolled in the study

Locations (12)

Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive

Bari, Apulia, Italy

Ospedale de Bellis; Reparto Medicina Generale

Castellana Grotte, Apulia, Italy

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)

Time frame: EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.

Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF

Time frame: EoF

Secondary Outcomes

Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)

Time frame: EoT, as defined in the predecessor study, was at Week 48 or Week 96

Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT

Time frame: EoT

Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF

Time frame: EoT and EoF

Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF

Time frame: EoT and EoF

Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF

Time frame: EoT and EoF

Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF

Time frame: EoT and EoF

Data from ClinicalTrials.gov

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