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: October 6, 2014
Last verified: October 2014
  Purpose

This cross-sectional multicenter study will evaluate the IL28B polymorphism in p atients with HBeAg-negative chronic hepatitis B treated with Pegasys (peginterfe ron alfa-2a) in the predecessor ML18253 study. The study consists of a single vi sit 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: Allocation: Non-Randomized
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 patients with sustained virological response (SVR) observed in ML18253 according to IL28B genotypes. SVR is defined as HBV DNA </= 2000 UI/ml at the end of the treatment-free follow-up [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with HBsAg clearance (defined as HBsAg <0.05 UI/ml) according to IL28B genotypes at end of treatment/end of follow-up in ML18253 [ Time Frame: approximately 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with HBsAg </= 10 IU/ml at end of treatment/end of follow-up according to IL28B genotypes in ML18253 [ Time Frame: approximately 24 weeks ] [ Designated as safety issue: No ]
  • HBsAg kinetic according to IL28B genotypes during treatment/follow-up in ML18253 [ Time Frame: approximately 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with virologic response at the end of treatment (HBV DNA </= 200 UI/ml) observed in ML18253 according to IL28B genotype. [ Time Frame: approximately 24 months ] [ 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
Last Updated: October 6, 2014
Health Authority: Italy: Agenzia Italiana del Farmaco (AIFA)

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

ClinicalTrials.gov processed this record on October 19, 2014