A clinical study with many of countries and sites participating. This study wants to look into the relationship of the genotype IL28B in patients from all over the world which are suffering from an inflammation of the liver with hepatitis C virus

An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes with Chronic Hepatitis C Disease Characteristics and Patient Demographics

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001096-39-SK

Enrollment

4200

Registered

2012-07-30

Start date

2012-07-10

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

Chronic hepatitis C MedDRA version: 14.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 10022891 - Investigations

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult (according to local legislation) male or female patients - Chronic hepatitis C (CHC) - Patients naïve to CHC treatment or patients who received prior interferon (IFN) based therapy for CHC for whom data on treatment received (type of therapy, dose, duration) and treatment outcome (i.e. rapid virological response [RVR], complete early virological response [cEVR], partial early virological response [pEVR], end of treatment response [EoT), sustained virological response [SVR], relapse, breakthrough, nonresponse) of prior therapy is available. In addition information on fibrosis stage prior to the previous treatment course is required. - Written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Co-infection with hepatitis B - History or other evidence of decompensated liver disease - History of major organ transplantation with an existing functional graft (including liver transplantation) - End stage renal disease

Design outcomes

Primary

Measure	Time frame
Main Objective: Correlation of Interleukin 28B (IL28B) genotypes rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG) with liver fibrosis related to CHC;Secondary Objective: - Correlation of IL28B genotypes (rs12979860 and rs8099917) with liver inflammation related to CHC - Correlation of IL28B genotypes (rs12979860 and rs8099917) with demographics in patients with CHC - Distribution of IL28B genotypes (rs12979860 and rs8099917) in patients with CHC in different HCV genotypes and in different countries - Correlation between the two IL28B genotypes (rs12979860 and rs8099917) in patients with CHC - Distribution of inosine triphosphatase (ITPA) genotypes rs1127354 (AA vs. CA vs. CC) and rs7270101 (CC vs. AC vs. AA) in patients with CHC in different HCV genotypes and in different countries - In treatment experienced patients, retrospective analysis of - Correlation between IL28B genotypes (rs12979860 and rs8099917) and previous treatment outcome - Correlation between ITPA genotypes (rs1127354 and rs7270101) and hemoglobin (Hb) decline during prior treatment;Primary end point(s): IL28B genotypes rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG);Timepoint(s) of evaluation of this end point: Please refer to protocol MV25600, Section 5, Schedule of Assessments and Procedures	—

Measure

Time frame

Main Objective: Correlation of Interleukin 28B (IL28B) genotypes rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG) with liver fibrosis related to CHC;Secondary Objective: - Correlation of IL28B genotypes (rs12979860 and rs8099917) with liver inflammation related to CHC - Correlation of IL28B genotypes (rs12979860 and rs8099917) with demographics in patients with CHC - Distribution of IL28B genotypes (rs12979860 and rs8099917) in patients with CHC in different HCV genotypes and in different countries - Correlation between the two IL28B genotypes (rs12979860 and rs8099917) in patients with CHC - Distribution of inosine triphosphatase (ITPA) genotypes rs1127354 (AA vs. CA vs. CC) and rs7270101 (CC vs. AC vs. AA) in patients with CHC in different HCV genotypes and in different countries - In treatment experienced patients, retrospective analysis of - Correlation between IL28B genotypes (rs12979860 and rs8099917) and previous treatment outcome - Correlation between ITPA genotypes (rs1127354 and rs7270101) and hemoglobin (Hb) decline during prior treatment;Primary end point(s): IL28B genotypes rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG);Timepoint(s) of evaluation of this end point: Please refer to protocol MV25600, Section 5, Schedule of Assessments and Procedures

—

Secondary

Measure	Time frame
Secondary end point(s): ITPA genotypes rs1127354 (AA vs. CA vs. CC) and rs7270101 (CC vs. AC vs. AA);Timepoint(s) of evaluation of this end point: Please refer to protocol MV25600, Section 5, Schedule of Assessments and Procedures	—

Countries

Argentina, Chile, Lebanon, Mexico, Pakistan, Serbia, Slovakia, Syria, Taiwan, Thailand, Turkey

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com004161688 1111

Outcome results

None listed

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