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Cross-sectional multicenter study evaluating the IL28B polymorphism in patients with HBeAg-negative chronic hepatitis B treated with pegylated interferon alfa-2a in the course of Peg.Be.Liver study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-002777-56-IT
Enrollment
Unknown
Registered
2012-08-31
Start date
2012-08-20
Completion date
Unknown
Last updated
2013-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBeAg-negative chronic hepatitis B MedDRA version: 15.0 Level: LLT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Pegasys Pharmaceutical Form: Solution for injection INN or Proposed INN: PEGINTERFERON ALFA-2A CAS Number: 198153-51-4 Current Sponsor code: RO0258310 Concentration unit: µg/ml microgram(s

Sponsors

ROCHE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Signature of the informed consent form for participation in this study; • Previous participation in study ML18253; • Administration of at least one dose of the study drug during ML18253 study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Patients not satisfying the above inclusion criteria will not be enrolled in the study.

Design outcomes

Primary

MeasureTime frame
Main Objective: Cross-sectional multicenter study evaluating the IL28B polymorphism in patients with HBeAg-negative chronic hepatitis B treated with pegylated interferon alfa-2a in the course of Peg.Be.Liver study.;Secondary Objective: • Evaluation of the association between IL28B polymorphism and HBsAg clearance observed at the end of treatment (EoT) and at the end of follow-up (EoF) in the predecessor ML18253 study; • Evaluation of the association between IL28B polymorphism and HBsAg = 10 IU/ml at EoT and EoF in the predecessor ML18253 study; • Evaluation of the association of IL28B polymorphism and HBsAg kinetic in the predecessor ML18253 study;Primary end point(s): Association between IL28B genotypes at rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG)and SVR (No vs. Yes) at EoF. SVR is defined as HBV DNA = 2.000 UI/ml.;Timepoint(s) of evaluation of this end point: -—

Secondary

MeasureTime frame
Secondary end point(s): • Association between IL28B genotypes at rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG) and SVR at EoT, defined as HBV DNA = 2.000 UI/ml; • Association between IL28B genotypes at rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG) and HBsAg clearance, defined as HBsAg < 0.05 IU/ml, at EoT; • Association between IL28B genotypes at rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG) and HBsAg clearance, defined as HBsAg < 0.05 IU/ml, at EoF; • Association between IL28B genotypes at rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG) and HBsAg < 10 IU/ml at EoT; • Association between IL28B genotypes at rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG) and HBsAg < 10 IU/ml at EoF; • Kinetic of HBsAg during treatment and follow-up by IL28B genotypes at rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG).;Timepoint(s) of evaluation of this end point: -—

Countries

Italy

Contacts

Public ContactHead of Clinical Operations

Roche S.p.A.

sergio.scaccabarozzi@roche.com039 247 5070

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026