A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Other: Interleukin 28B testing

Study type: Interventional

Funder types: Industry

Identifiers

NCT01675427

MV25600

Details and patient eligibility

About

This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients with HIV co-infection. There will be a single study visit for testing.

Enrollment: 4,766 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (according to local legislation) male or female patient
• Chronic hepatitis C (CHC)
• Patients naïve to CHC treatment or patients who received prior interferon-based therapy for CHC for whom data on treatment received and treatment outcome is available; information on fibrosis stage prior to previous treatment is also required

Exclusion criteria

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

Trial design

4,766 participants in 1 patient group

Chronic hepatitis C patients

Experimental group

Treatment:

Other: Interleukin 28B testing