A study to assess the viral activity in patients who failed to achieve sustained virologic response in Novartis-sponsored DEB025A2211 (CTRI - CTRI/2010/091/002967)

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 Alisporivirstudies for chronic Hepatitis C patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2012/10/003061

Enrollment

650

Registered

2012-10-15

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

Intervention1: N/A: N/A

Eligibility

Inclusion criteria

Inclusion criteria: 1.Written informed consent must be obtained before any assessment is performed. 2.Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent. 3.Have not achieved SVR24.

Exclusion criteria

Exclusion criteria: 1.Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of thatmedication, whichever is longer. 2.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
To determine the persistence of resistance associated variants associated with failure to previous alisporivir therapyTimepoint: N/A	—

Secondary

Measure	Time frame
1.To perform phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro 2.To monitor the changes in liver function and disease over time 3. To assess the development of hepatocellular carcinoma (HCC) 4.To assess the safety over time of previous alisporivir exposureTimepoint: N/A	—

Countries

India

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited

murugananthan.k@novartis.com022-24958545

Outcome results

None listed

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