A study to assess the durability of sustained virologic response in Alisporivirtreated chronic Hepatitis C patients

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2012/10/003066

Enrollment

2000

Registered

2012-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- chronic Hepatitis C

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed. 3. Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir 4. Have achieved SVR24 5. Are able to comply with the visit schedule

Exclusion criteria

Exclusion criteria: 1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer. 2. Use or planned use to start a new course of hepatitis C therapy

Design outcomes

Primary

Measure	Time frame
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 studyTimepoint: Nil	—

Secondary

Measure	Time frame
1. 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 2. To assess the impact of successful alisporivir treatment on the change in liver disease over time 3. To assess the development of hepatocellular carcinoma (HCC) 4. To assess the safety over time of previous alisporivir exposureTimepoint: Nil	—

Measure

Time frame

1. 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 2. To assess the impact of successful alisporivir treatment on the change in liver disease over time 3. To assess the development of hepatocellular carcinoma (HCC) 4. To assess the safety over time of previous alisporivir exposureTimepoint: Nil

—

Countries

Argentina, Australia, Belgium, Canada, France, Germany, Hong Kong, Hungary, India, Italy

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited,

murugananthan.k@novartis.com022-24958545

Outcome results