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.

A PHASE 4, BLOOD SAMPLE COLLECTION STUDY FOR EXPLORATORY EVALUATION OF THE ASSOCIATION OF SINGLE NUCLEOTIDE POLYMORPHISMS WITH TREATMENT RESPONSES FROM SUBJECTS WITH HBEANTIGEN POSITIVE OR NEGATIVE CHRONIC HEPATITIS B, WHO RECEIVED THERAPY FOR HEPATITIS B WITH PEGINTERFERON ALFA-2A 40KD (PEG-IFN) ± NUCLEOS(T)IDE ANALOGUE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001141-14-AT

Enrollment

700

Registered

2013-06-05

Start date

2013-10-01

Completion date

Unknown

Last updated

2015-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic liver disease caused by the hepatitis B virus. MedDRA version: 16.0 Level: LLT Classification code 10019743 Term: Hepatitis B virus (HBV) System Organ Class: 100000004848

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: Patients infected with HAV, HCV, or HIV

Design outcomes

Primary

Measure	Time frame
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 HBe-antigen positive or negative Chronic Hepatitis B (CHB), who have completed therapy with Peg-IFN ± nucleos(t)ide analogue. - 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- 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.	—

Measure

Time frame

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 HBe-antigen positive or negative Chronic Hepatitis B (CHB), who have completed therapy with Peg-IFN ± nucleos(t)ide analogue. - 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- 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

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Austria, Bulgaria, China, France, Germany, Greece, Italy, Korea, Republic of, New Zealand, Poland, Portugal, Romania, United Kingdom

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com+41616881111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026