A 3-year follow-up study of chronic hepatitis C patients treated with alisporivir to assess durability of sustained virologic response

A multi-centre 3-year follow-up study to assess the durability of sustained virologic response in alisporivir treated chronic hepatitis C patients - NA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006131-38-ES

Enrollment

2000

Registered

2012-04-12

Start date

2012-05-18

Completion date

Unknown

Last updated

2015-07-10

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

Conditions

Chronic hepatitis C in patients who achieved sustained virologic response (SVR24) on alisporivir in a Novartis-sponsored chronic Hepatitis C study. MedDRA version: 14.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C 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 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

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 -Use or planned use to start a new course of hepatitis C therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the durability of sustained virologic response after SVR24 has been achieved in patients treated with alisporivir in a Novartis-sponsored chronic Hepatitis C study.;Secondary Objective: -To determine whether subsequent detection of HCV RNA in patients who relapse following SVR24, represents the re-emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection. -To assess the impact of successful alisporivir treatment on the change in liver disease over time and to assess the development of hepatocellular carcinoma (HCC). -To assess the safety over time of previous alisporivir exposure.;Primary end point(s): To examine the proportion of patients who maintain HCV RNA viral load below lower limit of quantification (LOQ) at each scheduled time point.;Timepoint(s) of evaluation of this end point: During the 5 scheduled visits within three years.	—

Measure

Time frame

Main Objective: To assess the durability of sustained virologic response after SVR24 has been achieved in patients treated with alisporivir in a Novartis-sponsored chronic Hepatitis C study.;Secondary Objective: -To determine whether subsequent detection of HCV RNA in patients who relapse following SVR24, represents the re-emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection. -To assess the impact of successful alisporivir treatment on the change in liver disease over time and to assess the development of hepatocellular carcinoma (HCC). -To assess the safety over time of previous alisporivir exposure.;Primary end point(s): To examine the proportion of patients who maintain HCV RNA viral load below lower limit of quantification (LOQ) at each scheduled time point.;Timepoint(s) of evaluation of this end point: During the 5 scheduled visits within three years.

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Secondary

Measure	Time frame
Secondary end point(s): -HCV RNA viral load -The proportion of patients who normalize alanine aminotransferase (ALT) -Liver fibrosis evaluations using Fibrotest and elastography, and to monitor for any changes over time using ultrasound of the liver and spleen -The proportion of relapsed patients -The proportion of re-infected patients -The safety assessment will be based on the analyses of adverse events, vital signs and laboratory evaluations.;Timepoint(s) of evaluation of this end point: During the 5 scheduled visits within three years.	—

Measure

Time frame

Secondary end point(s): -HCV RNA viral load -The proportion of patients who normalize alanine aminotransferase (ALT) -Liver fibrosis evaluations using Fibrotest and elastography, and to monitor for any changes over time using ultrasound of the liver and spleen -The proportion of relapsed patients -The proportion of re-infected patients -The safety assessment will be based on the analyses of adverse events, vital signs and laboratory evaluations.;Timepoint(s) of evaluation of this end point: During the 5 scheduled visits within three years.

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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