NCT01697501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

November 8, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

July 10, 2015

Completed
Last Updated

April 10, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

September 28, 2012

Results QC Date

June 10, 2015

Last Update Submit

March 10, 2017

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Chronic hepatitis B patients

EXPERIMENTAL
Other: Interleukin 28B testing

Interventions

Interleukin 28B testingOTHER

Blood sampling for IL28B genotyping

Chronic hepatitis B patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive

Bari, Apulia, 70124, Italy

Location

Ospedale de Bellis; Reparto Medicina Generale

Castellana Grotte, Apulia, 70013, Italy

Location

Az. Osp. S. Sebastiano; Divisione Malattie Infettive

Caserta, Campania, 81100, Italy

Location

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

Napoli, Campania, 80131, Italy

Location

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

Bologna, Emilia-Romagna, 40138, Italy

Location

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

Parma, Emilia-Romagna, 43100, Italy

Location

Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

Milan, Lombardy, 20122, Italy

Location

Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale

Milan, Lombardy, 20122, Italy

Location

Uni Di Cagliari; Dept. Di Scienze Mediche

Cagliari, Sardinia, 09042, Italy

Location

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

Palermo, Sicily, 90127, Italy

Location

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

Pisa, Tuscany, 56124, Italy

Location

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

Padua, Veneto, 35128, Italy

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
1-800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2012

First Posted

October 2, 2012

Study Start

November 8, 2012

Primary Completion

June 21, 2013

Study Completion

June 21, 2013

Last Updated

April 10, 2017

Results First Posted

July 10, 2015

Record last verified: 2017-03

Locations

IT(12)