A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253

Hepatitis B, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697501
• Other study ID #: ML28470
• Secondary ID: 2012-002777-56
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2012
• Last updated: December 1, 2015
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Agenzia Italiana del Farmaco (AIFA)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Other:
• Interleukin 28B testing
Blood sampling for IL28B genotyping

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.	No
Primary	Percentage of Participants With SVR Defined as HBV DNA = 2000 IU/ml at IL28B Genotype rs8099917 at EoF		EoF	No
Secondary	Percentage of Participants With HBV DNA = 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)		EoT, as defined in the predecessor study, was at Week 48 or Week 96	No
Secondary	Percentage of Participants With HBV DNA = 2000 IU/ml at IL28B Genotype rs8099917 at EoT		EoT	No
Secondary	Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF		EoT and EoF	No
Secondary	Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF		EoT and EoF	No
Secondary	Percentage of Participants With HBsAg = 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF		EoT and EoF	No
Secondary	Percentage of Participants With HBsAg = 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF		EoT and EoF	No