EUCTR2011-006131-38-ITActive, not recruitingNot Applicable
A multi-centre 3-year follow-up study to assess the durability of sustained virologic response in Alisporivirtreated chronic Hepatitis C patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- OVARTIS FARMA
- Enrollment
- 2,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-Written informed consent must be obtained before any assessment is performed -Males or females must be aged 18 years or older -Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir -Have achieved SVR24 -Be able to comply with visit schedule
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 700
Exclusion Criteria
- •-Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer XML File Identifier: K6aU06lo1HleGgyLeCoFO4OY2Zs= Page 10/20 -Use or planned use to start a new course of hepatitis C therapy
Investigators
Similar Trials
Active, not recruiting
Phase 1
A 3-year follow-up study in chronic hepatitis C patients who failed to achieve sustained virologic response during Novartis-sponsored alisporivir studiesChronic hepatitis C patients who failed to achieve sustained virologic response (SVR24) on alisporivir or direct-acting antivirals (DAA) in previous Novartis-sponsored studies.MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-006132-24-GBovartis Pharma Services AG105
Active, not recruiting
Not Applicable
A 3-year follow-up study in chronic hepatitis C patients who failed to achieve sustained virologic response during Novartis-sponsored alisporivir studiesEUCTR2011-006132-24-HUovartis Pharma Services AG650
Active, not recruiting
Not Applicable
A 3-year follow-up study of chronic hepatitis C patients treated with alisporivir to assess durability of sustained virologic responseEUCTR2011-006131-38-GBovartis Pharma Services AG2,000
Active, not recruiting
Phase 3
A study to assess thedurability of sustained virologic response in Alisporivirtreatedchronic Hepatitis C patientsCTRI/2012/10/003066ovartis Healthcare Pvt Lt2,000
Active, not recruiting
Not Applicable
A 3-year follow-up study in chronic hepatitis C patients who failed to achieve sustained virologic response during Novartis-sponsored alisporivir studiesChronic hepatitis C patients who failed to achieve sustained virologic response (SVR24) on alisporivir or direct-acting antivirals (DAA) in previous Novartis-sponsored studies.MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-006132-24-ESovartis Farmaceutica, S.A.650