EUCTR2011-001096-39-SK
Active, not recruiting
Phase 1
An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes with Chronic Hepatitis C Disease Characteristics and Patient Demographics
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- F.Hoffmann-La Roche Ltd.
- Enrollment
- 4200
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Adult (according to local legislation) male or female
- •\- 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
Exclusion Criteria
- •\- Co\-infection with hepatitis B
- •\- History or other evidence of decompensated liver
- •\- History of major organ transplantation with an existing functional graft (including liver transplantation)
- •\- End stage renal disease
Outcomes
Primary Outcomes
Not specified
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