A 3-year follow-up study in chronic hepatitis C patients who failed to achieve sustained virologic response during Novartis-sponsored alisporivir studies

A multi-centre 3-year follow-up study to assess the viral activity in patients who failed to achieve sustained virologic response in Novartis-sponsored alisporivir studies for chronic hepatitis C patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006132-24-ES

Enrollment

650

Registered

2012-04-12

Start date

2012-05-18

Completion date

Unknown

Last updated

2013-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic 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: 14.1 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Alisporivir Product Code: DEB025 Pharmaceutical Form: Capsule, soft CAS Number: 254435-95-5 Other descriptive name: ALISPORIVIR Concentration unit: mg milligram(s) Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Written informed consent must be obtained before any assessment is performed -Males or females aged 18 or greater -Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent -Have not acheived SVR24 -Be able to comply with visit schedule 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 650 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65

Exclusion criteria

Exclusion criteria: -Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer -Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the persistence of resistance associated variants associated with failure to previous alisporivir therapy.;Secondary Objective: -To perform phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro -To monitor the changes in liver function and disease over time -To assess the development of hepatocellular carcinoma (HCC) -To assess the safety over time of previous alisporivir exposure;Primary end point(s): Time to reversion to wild-type for subjects who had genotypic change (resistance associated variants) in the feeder study.;Timepoint(s) of evaluation of this end point: During 11 scheduled visits within three years according to the assessment schedule	—

Measure

Time frame

Main Objective: To determine the persistence of resistance associated variants associated with failure to previous alisporivir therapy.;Secondary Objective: -To perform phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro -To monitor the changes in liver function and disease over time -To assess the development of hepatocellular carcinoma (HCC) -To assess the safety over time of previous alisporivir exposure;Primary end point(s): Time to reversion to wild-type for subjects who had genotypic change (resistance associated variants) in the feeder study.;Timepoint(s) of evaluation of this end point: During 11 scheduled visits within three years according to the assessment schedule

—

Secondary

Measure	Time frame
Secondary end point(s): -HCV RNA viral load -Liver fibrosis evaluations using Fibrotest and elastography, and to monitor for any changes over time using ultrasound of the liver and spleen -The assessment of safety will be based on the analyses of adverse events, vital signs and laboratory evaluations;Timepoint(s) of evaluation of this end point: During 11 scheduled visits within three years according to the assessment schedule	—

Measure

Time frame

Secondary end point(s): -HCV RNA viral load -Liver fibrosis evaluations using Fibrotest and elastography, and to monitor for any changes over time using ultrasound of the liver and spleen -The assessment of safety will be based on the analyses of adverse events, vital signs and laboratory evaluations;Timepoint(s) of evaluation of this end point: During 11 scheduled visits within three years according to the assessment schedule

—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, Philippines, Poland, Romania, Russian Federation, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam

Contacts

Public ContactInma Bosch

Novartis Farmaceutica, S.A.

eecc.novartis@novartis.com+34933064200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026