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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

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ClinicalTrials.gov Identifier: NCT01697501
Recruitment Status : Completed
First Posted : October 2, 2012
Results First Posted : July 10, 2015
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Other: Interleukin 28B testing Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : November 8, 2012
Actual Primary Completion Date : June 21, 2013
Actual Study Completion Date : June 21, 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Chronic hepatitis B patients Other: Interleukin 28B testing
Blood sampling for IL28B genotyping


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
  2. Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF [ Time Frame: EoF ]

Secondary Outcome Measures :
  1. 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 ]
  2. Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT [ Time Frame: EoT ]
  3. Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF [ Time Frame: EoT and EoF ]
  4. Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF [ Time Frame: EoT and EoF ]
  5. Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF [ Time Frame: EoT and EoF ]
  6. Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF [ Time Frame: EoT and EoF ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697501


Locations
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Italy
Az. Osp. S. Sebastiano; Divisione Malattie Infettive
Caserta, Campania, Italy, 81100
Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia
Napoli, Campania, Italy, 80131
UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
Bologna, Emilia-Romagna, Italy, 40138
Az. Osp. Uni Ria Di Parma; Gastro-Enterology
Parma, Emilia-Romagna, Italy, 43100
Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
Milano, Lombardia, Italy, 20122
Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale
Milano, Lombardia, Italy, 20122
Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive
Bari, Puglia, Italy, 70124
Ospedale de Bellis; Reparto Medicina Generale
Castellana Grotte, Puglia, Italy, 70013
Uni Di Cagliari; Dept. Di Scienze Mediche
Cagliari, Sardegna, Italy, 09042
Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia
Palermo, Sicilia, Italy, 90127
Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
Pisa, Toscana, Italy, 56124
Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.
Padova, Veneto, Italy, 35128
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01697501    
Other Study ID Numbers: ML28470
2012-002777-56 ( EudraCT Number )
First Posted: October 2, 2012    Key Record Dates
Results First Posted: July 10, 2015
Last Update Posted: April 10, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic