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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

September 28, 2012
March 10, 2017
November 8, 2012
June 21, 2013   (Final data collection date for primary outcome measure)
  • 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 ]
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 ]
Complete list of historical versions of study NCT01697501 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
  • HBsAg kinetic according to IL28B genotypes during treatment/follow-up in ML18253 [ Time Frame: approximately 24 weeks ]
  • 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 ]
Not Provided
Not Provided
 
A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253
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
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
Hepatitis B, Chronic
Other: Interleukin 28B testing
Blood sampling for IL28B genotyping
Experimental: Chronic hepatitis B patients
Intervention: Other: Interleukin 28B testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
June 21, 2013
June 21, 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01697501
ML28470
2012-002777-56 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP