Hepatitis C
Conditions
Keywords
Chronic hepatitis C
Brief 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.
Interventions
DRUGAlisporivir
Intervention of interest; follow-up after ALV-active study
Sponsors
Debiopharm International SA
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provides written informed consent before any assessment is performed 2. Is male or female aged ≥18 3. Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir 4. Has achieved SVR24 5. Is able to comply with the visit schedule
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. 3. No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | up to 120 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | at Week 48 | Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir. |
Countries
Argentina, Australia, Belgium, Canada, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, Poland, Romania, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Vietnam
Participant flow
Recruitment details
The study was conducted in 127 centers across 22 countries globally.
Pre-assignment details
Participants transferring from Study 2211 were allocated to the From Study 2211 group. These were evaluated as INF-free and Overall subgroups for efficacy analyses.
Participants by arm
| Arm | Count |
|---|---|
| From Study 2210 All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study. | 164 |
| From Study 2301 All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study. | 397 |
| From Study 2211 All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. | 162 |
| Total | 723 |
Baseline characteristics
| Characteristic | From Study 2210 | From Study 2301 | From Study 2211 | Total |
|---|---|---|---|---|
| Age, Continuous | 52.5 years STANDARD_DEVIATION 9.89 | 46.4 years STANDARD_DEVIATION 11.7 | 43.7 years STANDARD_DEVIATION 10.89 | 47.2 years STANDARD_DEVIATION 11.53 |
| Sex: Female, Male Female | 58 Participants | 182 Participants | 61 Participants | 301 Participants |
| Sex: Female, Male Male | 106 Participants | 215 Participants | 101 Participants | 422 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 164 | 0 / 397 | 0 / 54 | 0 / 162 |
| serious Total, serious adverse events | 7 / 164 | 8 / 397 | 1 / 54 | 3 / 162 |
Outcome results
Primary
Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48
Time frame: up to 120 Weeks
Population: Full analysis set (FAS), defined as all participants who enrolled into this study and had at least one HCV RNA assessment, unless excluded due to protocol deviations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| From Study 2210 | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 1 (n=152,371,53,152) | 96.7 percentage of participants |
| From Study 2210 | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 24 (n=148,346,49,148) | 100.0 percentage of participants |
| From Study 2210 | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 48 (n=146,337,46,140) | 100.0 percentage of participants |
| From Study 2210 | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 96 (n=7,0,36,90) | 100.0 percentage of participants |
| From Study 2210 | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 120 (n=0,0,1,3) | 0.0 percentage of participants |
| From Study 2210 | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Overall (n=161,383,53,160) | 96.9 percentage of participants |
| From Study 2301 | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Overall (n=161,383,53,160) | 99.2 percentage of participants |
| From Study 2301 | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 96 (n=7,0,36,90) | 0.0 percentage of participants |
| From Study 2301 | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 1 (n=152,371,53,152) | 99.5 percentage of participants |
| From Study 2301 | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 48 (n=146,337,46,140) | 99.7 percentage of participants |
| From Study 2301 | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 24 (n=148,346,49,148) | 100.0 percentage of participants |
| From Study 2301 | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 120 (n=0,0,1,3) | 0.0 percentage of participants |
| From Study 2211 IFN-free | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 24 (n=148,346,49,148) | 98.0 percentage of participants |
| From Study 2211 IFN-free | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 48 (n=146,337,46,140) | 100.0 percentage of participants |
| From Study 2211 IFN-free | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 96 (n=7,0,36,90) | 100.0 percentage of participants |
| From Study 2211 IFN-free | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Overall (n=161,383,53,160) | 98.1 percentage of participants |
| From Study 2211 IFN-free | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 120 (n=0,0,1,3) | 100.0 percentage of participants |
| From Study 2211 IFN-free | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 1 (n=152,371,53,152) | 100.0 percentage of participants |
| From Study 2211 Overall | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 120 (n=0,0,1,3) | 100.0 percentage of participants |
| From Study 2211 Overall | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Overall (n=161,383,53,160) | 99.4 percentage of participants |
| From Study 2211 Overall | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 24 (n=148,346,49,148) | 99.3 percentage of participants |
| From Study 2211 Overall | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 96 (n=7,0,36,90) | 100.0 percentage of participants |
| From Study 2211 Overall | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 1 (n=152,371,53,152) | 100.0 percentage of participants |
| From Study 2211 Overall | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | Week 48 (n=146,337,46,140) | 100.0 percentage of participants |
Secondary
Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48.
Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir.
Time frame: at Week 48
Population: Full analysis set. In the categories, n is the number of subjects in FAS in the appropriate study group with normal ALT at visit; for Overall - at all available visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| From Study 2210 | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 120 (n=0,0,1,3) | 0.0 percentage of participants |
| From Study 2210 | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 24 (n=150,360,50,151) | 84.0 percentage of participants |
| From Study 2210 | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Overall (n=161,383,52,159) | 78.9 percentage of participants |
| From Study 2210 | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 1 (n=161,383,50,156) | 88.8 percentage of participants |
| From Study 2210 | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 96 (n=7,0,36,92) | 85.7 percentage of participants |
| From Study 2210 | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 48 (n=152,355,47,141) | 88.2 percentage of participants |
| From Study 2301 | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 120 (n=0,0,1,3) | 0.0 percentage of participants |
| From Study 2301 | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 96 (n=7,0,36,92) | 0.0 percentage of participants |
| From Study 2301 | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 1 (n=161,383,50,156) | 94.0 percentage of participants |
| From Study 2301 | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 24 (n=150,360,50,151) | 93.9 percentage of participants |
| From Study 2301 | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 48 (n=152,355,47,141) | 91.5 percentage of participants |
| From Study 2301 | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Overall (n=161,383,52,159) | 88.5 percentage of participants |
| From Study 2211 IFN-free | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 48 (n=152,355,47,141) | 87.2 percentage of participants |
| From Study 2211 IFN-free | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 24 (n=150,360,50,151) | 82.0 percentage of participants |
| From Study 2211 IFN-free | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 120 (n=0,0,1,3) | 100.0 percentage of participants |
| From Study 2211 IFN-free | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 96 (n=7,0,36,92) | 94.4 percentage of participants |
| From Study 2211 IFN-free | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Overall (n=161,383,52,159) | 78.8 percentage of participants |
| From Study 2211 IFN-free | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 1 (n=161,383,50,156) | 96.0 percentage of participants |
| From Study 2211 Overall | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Overall (n=161,383,52,159) | 83.6 percentage of participants |
| From Study 2211 Overall | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 24 (n=150,360,50,151) | 89.4 percentage of participants |
| From Study 2211 Overall | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 48 (n=152,355,47,141) | 91.5 percentage of participants |
| From Study 2211 Overall | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 1 (n=161,383,50,156) | 95.5 percentage of participants |
| From Study 2211 Overall | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 96 (n=7,0,36,92) | 93.5 percentage of participants |
| From Study 2211 Overall | Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Week 120 (n=0,0,1,3) | 100.0 percentage of participants |