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

Phase 3

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Other: Interleukin 28B testing

• Registration Number: NCT01697501
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Study Start: 2012-11-08
• Primary Completion: 2013-06-21
• Study Completion: 2013-06-21
• Results First Submitted: 2015-06-10
• Results First Submitted QC: 2015-07-07
• Results First Posted: 2015-07-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chronic hepatitis B patients	Interleukin 28B testing	-

Primary Outcome Measures

Name	Time	Method
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)	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	EoF

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)	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	EoT
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF	EoT and EoF
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF	EoT and EoF
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF	EoT and EoF
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF	EoT and EoF

Trial Locations

Locations (12)

Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia; 🇮🇹 Milano, Lombardia, Italy

Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive; 🇮🇹 Bari, Puglia, Italy

Uni Di Cagliari; Dept. Di Scienze Mediche; 🇮🇹 Cagliari, Sardegna, Italy

Az. Osp. Uni Ria Di Parma; Gastro-Enterology; 🇮🇹 Parma, Emilia-Romagna, Italy

Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia; 🇮🇹 Napoli, Campania, Italy

Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale; 🇮🇹 Milano, Lombardia, Italy

UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In; 🇮🇹 Bologna, Emilia-Romagna, Italy

Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.; 🇮🇹 Padova, Veneto, Italy

Ospedale de Bellis; Reparto Medicina Generale; 🇮🇹 Castellana Grotte, Puglia, Italy

Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia; 🇮🇹 Palermo, Sicilia, Italy

Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia; 🇮🇹 Pisa, Toscana, Italy

Az. Osp. S. Sebastiano; Divisione Malattie Infettive; 🇮🇹 Caserta, Campania, Italy