Clinical trial NCT01697501: A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-02
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.
measure: Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF
timeFrame: EoF
Secondary outcomes:
measure: Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)
timeFrame: EoT, as defined in the predecessor study, was at Week 48 or Week 96
measure: Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT
timeFrame: EoT
measure: Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
timeFrame: EoT and EoF
measure: Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
timeFrame: EoT and EoF
measure: Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
timeFrame: EoT and EoF
measure: Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
timeFrame: EoT and EoF
Other outcomes:
Locations:
city: Caserta
country: Italy
facility: Az. Osp. S. Sebastiano; Divisione Malattie Infettive
state: Campania
city: Napoli
country: Italy
facility: Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia
state: Campania
city: Bologna
country: Italy
facility: UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
state: Emilia-Romagna
city: Parma
country: Italy
facility: Az. Osp. Uni Ria Di Parma; Gastro-Enterology
state: Emilia-Romagna
city: Milano
country: Italy
facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
state: Lombardia
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale
state: Lombardia
city: Bari
country: Italy
facility: Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive
state: Puglia
city: Castellana Grotte
country: Italy
facility: Ospedale de Bellis; Reparto Medicina Generale
state: Puglia
city: Cagliari
country: Italy
facility: Uni Di Cagliari; Dept. Di Scienze Mediche
state: Sardegna
city: Palermo
country: Italy
facility: Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia
state: Sicilia
city: Pisa
country: Italy
facility: Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
state: Toscana
city: Padova
country: Italy
facility: Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: