Completed
An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes With Patient Demographics and Disease Characteristics in Patients With Chronic Hepatitis C
What is being tested
Interleukin 28B testing
Other
Who is being recruted
Blood-Borne Infections+14
+ Chronic Disease
+ Communicable Diseases
Over 18 Years
+7 Eligibility Criteria
How is the trial designed
Phase 4
Interventional
Study Start: August 2011
Summary
Principal SponsorHoffmann-La Roche
Last updated: August 26, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2011
Actual date on which the first participant was enrolled.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.
Principal SponsorHoffmann-La Roche
Last updated: August 26, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
4766 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesHepatitisHepatitis, ChronicHepatitis, Viral, HumanHepatitis CInfectionsLiver DiseasesPathologic ProcessesRNA Virus InfectionsPathological Conditions, Signs and SymptomsVirus DiseasesFlaviviridae InfectionsDisease AttributesHepatitis C, Chronic
Criteria
3 inclusion criteria required to participate
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
4 exclusion criteria prevent from participating
Co-infection with hepatitis B
End stage renal disease
History of major organ transplantation with an existing functional graft (including liver transplantation)
History or evidence of decompensated liver disease
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 210 locations
Alexandria, United StatesOpen in Google Maps
Buenos Aires, Argentina
Mar del Plata, Argentina
Antwerp, Belgium
Completed210 Study Centers