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: July 7, 2015
Last verified: July 2015
  Purpose

This was a phase IIIb, interventional, cross sectional, national, multicenter study.

The study was carried out in one single visit, in which patients who took part in the predecessor ML18253 study and were eligible for participation in the present study underwent a blood sample for the determination of the IL28B polymorphism. A phone follow-up took place one week after the visit for the assessment of adverse events.


Condition Intervention Phase
Hepatitis B, Chronic
Other: Interleukin 28B testing
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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. ] [ Designated as safety issue: No ]
  • Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF [ Time Frame: EoF ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT [ Time Frame: EoT ] [ Designated as safety issue: No ]
  • Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF [ Time Frame: EoT and EoF ] [ Designated as safety issue: No ]
  • Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF [ Time Frame: EoT and EoF ] [ Designated as safety issue: No ]
  • Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF [ Time Frame: EoT and EoF ] [ Designated as safety issue: No ]
  • Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF [ Time Frame: EoT and EoF ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: November 2012
Study Completion Date: June 2013
Primary Completion Date: June 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
Genders Eligible for Study:   Both
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
Caserta, Campania, Italy, 81100
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40138
Parma, Emilia-Romagna, Italy, 43100
Milano, Lombardia, Italy, 20122
Bari, Puglia, Italy, 70124
Castellana Grotte, Puglia, Italy, 70013
Cagliari, Sardegna, Italy, 09042
Palermo, Sicilia, Italy, 90127
Pisa, Toscana, Italy, 56124
Padova, Veneto, Italy, 35128
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01697501     History of Changes
Other Study ID Numbers: ML28470, 2012-002777-56
Study First Received: September 28, 2012
Results First Received: June 10, 2015
Last Updated: July 7, 2015
Health Authority: Italy: Agenzia Italiana del Farmaco (AIFA)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 30, 2015