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Trial record 1 of 43 for:    IL28B Polymorphism in
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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01697501
First received: September 28, 2012
Last updated: March 10, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Hepatitis B, Chronic Other: Interleukin 28B testing Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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) [ Time Frame: 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 [ Time Frame: EoF ]

Secondary Outcome Measures:
  • 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 ]
  • Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT [ Time Frame: EoT ]
  • Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF [ Time Frame: EoT and EoF ]
  • Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF [ Time Frame: EoT and EoF ]
  • Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF [ Time Frame: EoT and EoF ]
  • Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF [ Time Frame: EoT and EoF ]

Enrollment: 88
Actual Study Start Date: November 8, 2012
Study Completion Date: June 21, 2013
Primary Completion Date: June 21, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chronic hepatitis B patients Other: Interleukin 28B testing
Blood sampling for IL28B genotyping

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697501

Locations
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
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01697501     History of Changes
Other Study ID Numbers: ML28470
2012-002777-56 ( EudraCT Number )
Study First Received: September 28, 2012
Results First Received: June 10, 2015
Last Updated: March 10, 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 22, 2017