Phase 3
Completed N=723
Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients
Source: ClinicalTrials.gov NCT02753699 ↗Enrolled (actual)
723
Serious AEs
2.5%
Results posted
Aug 2016
Primary outcomePrimary: Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 — 96.7; 99.5; 100.0; 100.0 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time.
Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 |
96.7; 99.5; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. |
88.8; 94.0; 96.0; 95.5; 84.0; 93.9 | — |
Eligibility Criteria
Inclusion Criteria
- Provides written informed consent before any assessment is performed
- Is male or female aged ≥18
- Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
- Has achieved SVR24
- Is able to comply with the visit schedule
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.
- No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.
Data sourced from ClinicalTrials.gov (NCT02753699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.