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

Roche

Status and phase: Completed; Phase 3

Conditions: Hepatitis B, Chronic

Treatments: Other: Interleukin 28B testing

Study type: Interventional

Funder types: Industry

Identifiers

NCT01697501

2012-002777-56 (EudraCT Number)

ML28470

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Chronic hepatitis B patients

Experimental group

Treatment:

Other: Interleukin 28B testing