Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: November 3, 2014
Last verified: November 2014

September 28, 2012
November 3, 2014
November 2012
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01697501 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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 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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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 2013
June 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01697501
ML28470, 2012-002777-56
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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