A phase 4 blood sample collection study to evaluate if specific differences in genes are associated with differences in treatment response in patients with chronic liver disease caused by the hepatitis B virus who have been treated with Pegasys with or without antiviral drugs called nucleoside or nucleotide analogs.
- Conditions
- Chronic liver disease caused by the hepatitis B virus.MedDRA version: 16.0Level: LLTClassification code 10019743Term: Hepatitis B virus (HBV)System Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2013-001141-14-AT
- Lead Sponsor
- F.Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
• Previously enrolled in a Roche study and treated for CHB for at least 24 weeks with Peg-IFN ± nucleoside analogue (lamivudine or entacavir) or Peg-IFN ± nucleotide analogue (adefovir) with =24-week post-treatment follow-up or;
• Treated in general practice for CHB with Peg-IFN according to standard of care and in line with the current summary of product characteristics (SPC) / local labeling who have no contra-indication to Peg-IFN therapy as per the local label and have been
treated with Peg-IFN for at least 24 weeks and have =24-week post-treatment response available at the time of blood collection.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
Patients infected with HAV, HCV, or HIV
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable;Main Objective: - Using genome-wide association study (GWAS) approach to retrospectively evaluate the association of single nucleotide polymorphisms with =24-week post-treatment follow-up and/or 12-week and/or 24-week on-treatment responses in subjects with<br>HBe-antigen positive or negative Chronic Hepatitis B (CHB), who have completed therapy with Peg-IFN ± nucleos(t)ide analogue.<br>- Using genome-wide association study (GWAS) approach to retrospectively evaluate the association of functional exonic markers with =24-week post-treatment follow-up and/or 12-<br>week and/or 24-week on-treatment responses in subjects with HBe-antigen positive or negative Chronic Hepatitis B (CHB), who have completed therapy with Peg-IFN ± nucleos(t)ide analogue.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable