Hepatitis C, Chronic
Conditions
Keywords
Hepatitis C, chronic
Brief summary
Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies
Detailed description
The purpose of this study was to follow patients from the feeder studies who have not achieved SVR24 to assess their viral activity, and to assess the changes in liver function and disease, and post-treatment safety over time.
Interventions
DRUGPrevious treatment in DEB025 study
Follow-up after DEB025 active study
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females aged ≥18 2. Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent (DAA) 3. Have not achieved SVR24
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. 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 | Description |
|---|---|---|
| HCV RNA Sequencing | 27 months | Persistence of resistance associated variants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Parameters as Measured by HCV RNA Sequencing | 27 months | Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro |
| Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters | 27 months | Changes in liver function and disease over time |
| Safety Parameters as Measured by Liver UltraSound and Lab Parameters | 27 months | Development of hepatocellular carcinoma (HCC) |
| Safety Parameters | 27 months | Safety over time of previous alisporivir exposure |
Countries
Australia, Belgium, Canada, Germany, Hungary, India, Italy, Poland, Puerto Rico, Romania, South Korea, Spain, Taiwan, Thailand, United States, Vietnam
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| From Study 2210 (N=56) Follow up from feeder study NCT01183169 | 56 |
| From Study 2301 (N=36) Follow up from withdrawn feeder study NCT01318694 | 36 |
| Study 2211 - Overall (N=13) Follow up from feeder study NCT01215643 | 13 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | New therapy for study indication | 4 | 0 | 0 |
| Overall Study | Patient/guardian decision | 1 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 1 |
| Overall Study | Study terminated by sponsor | 50 | 34 | 11 |
Baseline characteristics
| Characteristic | From Study 2301 (N=36) | From Study 2210 (N=56) | Study 2211 - Overall (N=13) | Total |
|---|---|---|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 10.57 | 52.7 years STANDARD_DEVIATION 9.86 | 46.5 years STANDARD_DEVIATION 7.88 | 52.3 years STANDARD_DEVIATION 10.06 |
| Baseline HCV RNA Load (log10 IU/mL) | 6.19 log10 IU/mL STANDARD_DEVIATION 0.5171 | 6.32 log10 IU/mL STANDARD_DEVIATION 1.3375 | 6.17 log10 IU/mL STANDARD_DEVIATION 1.1974 | 6.26 log10 IU/mL STANDARD_DEVIATION 1.0959 |
| BMI | 25.54 kg/m^2 STANDARD_DEVIATION 4.08 | 26.35 kg/m^2 STANDARD_DEVIATION 3.76 | 26.24 kg/m^2 STANDARD_DEVIATION 4.12 | 26.06 kg/m^2 STANDARD_DEVIATION 3.89 |
| Race/Ethnicity, Customized Asian | 12 participants | 12 participants | 6 participants | 30 participants |
| Race/Ethnicity, Customized Black | 0 participants | 3 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Caucasian | 24 participants | 40 participants | 6 participants | 70 participants |
| Race/Ethnicity, Customized Native American | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Pacific Islander | 0 participants | 0 participants | 0 participants | 0 participants |
| Sex: Female, Male Female | 22 Participants | 23 Participants | 4 Participants | 49 Participants |
| Sex: Female, Male Male | 14 Participants | 33 Participants | 9 Participants | 56 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 | 1 / 53 | 1 / 33 | 2 / 6 | 4 / 12 |
| serious Total, serious adverse events | 3 / 53 | 0 / 33 | 0 / 6 | 0 / 12 |
Outcome results
Primary
HCV RNA Sequencing
Persistence of resistance associated variants
Time frame: 27 months
Population: There was no hypothesis testing in this study, as the study was prematurely terminated.~4 patients with resistance associated variants have been identified at study start. Study was not powered for 105 participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Arms | HCV RNA Sequencing | 4 Number of particiants |
Secondary
Safety Parameters
Safety over time of previous alisporivir exposure
Time frame: 27 months
Population: There was no hypothesis testing as the study was prematurely terminated. AE and SAE data are provided in the Adverse Events section~There was no hypothesis testing in this study, as the study was prematurely terminated.~Study was powered for 105 participants, not 650~No data are available because data were not collected
Secondary
Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters
Changes in liver function and disease over time
Time frame: 27 months
Population: There was no hypothesis testing in this study, as the study was prematurely terminated.~No data for any pre-specified Outcomes were analyzed.~There was no hypothesis testing in this study, as the study was prematurely terminated.~Study was powered for 105 participants, not 650~No data are available because data were not collected
Secondary
Safety Parameters as Measured by HCV RNA Sequencing
Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro
Time frame: 27 months
Population: There was no hypothesis testing in this study, as the study was prematurely terminated.~Study was powered for efficacy of 650 participants, and only 105 were randomized~No data are available because data were not collected
Secondary
Safety Parameters as Measured by Liver UltraSound and Lab Parameters
Development of hepatocellular carcinoma (HCC)
Time frame: 27 months
Population: There was no hypothesis testing in this study, as the study was prematurely terminated.~No data for any pre-specified Outcomes were analyzed.~There was no hypothesis testing in this study, as the study was prematurely terminated.~Study was powered for 105 participants, not 650~No data are available because data were not collected