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

Primary Purpose

Hepatitis B, Chronic

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Interleukin 28B testing

About this trial

This is an interventional other trial for Hepatitis B, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Az. Osp. S. Sebastiano; Divisione Malattie Infettive
Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia
UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
Az. Osp. Uni Ria Di Parma; Gastro-Enterology
Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale
Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive
Ospedale de Bellis; Reparto Medicina Generale
Uni Di Cagliari; Dept. Di Scienze Mediche
Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia
Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chronic hepatitis B patients

Arm Description

Outcomes

Primary Outcome Measures

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)

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

Secondary Outcome Measures

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

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

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

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

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

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

Full Information

NCT ID

NCT01697501

First Posted

September 28, 2012

Last Updated

March 10, 2017

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01697501

Brief Title

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

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

November 8, 2012 (Actual)

Primary Completion Date

June 21, 2013 (Actual)

Study Completion Date

June 21, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B, Chronic

7. Study Design

Primary Purpose

Other

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chronic hepatitis B patients

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Interleukin 28B testing

Intervention Description

Blood sampling for IL28B genotyping

Primary Outcome Measure Information:

Title

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.

Title

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

Time Frame

EoF

Secondary Outcome Measure Information:

Title

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

Title

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

Time Frame

EoT

Title

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

Time Frame

EoT and EoF

Title

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

Time Frame

EoT and EoF

Title

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

Time Frame

EoT and EoF

Title

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

Time Frame

EoT and EoF

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Az. Osp. S. Sebastiano; Divisione Malattie Infettive

City

Caserta

State/Province

Campania

ZIP/Postal Code

81100

Country

Italy

Facility Name

Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia

City

Napoli

State/Province

Campania

ZIP/Postal Code

80131

Country

Italy

Facility Name

UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Az. Osp. Uni Ria Di Parma; Gastro-Enterology

City

Parma

State/Province

Emilia-Romagna

ZIP/Postal Code

43100

Country

Italy

Facility Name

Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20122

Country

Italy

Facility Name

Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20122

Country

Italy

Facility Name

Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive

City

Bari

State/Province

Puglia

ZIP/Postal Code

70124

Country

Italy

Facility Name

Ospedale de Bellis; Reparto Medicina Generale

City

Castellana Grotte

State/Province

Puglia

ZIP/Postal Code

70013

Country

Italy

Facility Name

Uni Di Cagliari; Dept. Di Scienze Mediche

City

Cagliari

State/Province

Sardegna

ZIP/Postal Code

09042

Country

Italy

Facility Name

Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia

City

Palermo

State/Province

Sicilia

ZIP/Postal Code

90127

Country

Italy

Facility Name

Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia

City

Pisa

State/Province

Toscana

ZIP/Postal Code

56124

Country

Italy

Facility Name

Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.

City

Padova

State/Province

Veneto

ZIP/Postal Code

35128

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

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