Completed

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

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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
See all eligibility criteria
How is the trial designed

Phase 4
Interventional
Study Start: August 2011
See protocol details

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

Experimental

Study 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