Trial Outcomes & Findings for 3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study (NCT NCT02465203)
NCT ID: NCT02465203
Last Updated: 2018-01-12
Results Overview
Persistence of resistance associated variants
TERMINATED
PHASE3
105 participants
27 months
2018-01-12
Participant Flow
Participant milestones
| Measure |
From Study 2210 (N=56)
Follow up from feeder study NCT01183169
|
From Study 2301 (N=36)
Follow up from withdrawn feeder study NCT01318694
|
From Study 2211 - Overall (N=13)
Follow up from feeder study NCT01215643
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
36
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
56
|
36
|
13
|
Reasons for withdrawal
| Measure |
From Study 2210 (N=56)
Follow up from feeder study NCT01183169
|
From Study 2301 (N=36)
Follow up from withdrawn feeder study NCT01318694
|
From Study 2211 - Overall (N=13)
Follow up from feeder study NCT01215643
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
|
Overall Study
Study terminated by sponsor
|
50
|
34
|
11
|
|
Overall Study
New therapy for study indication
|
4
|
0
|
0
|
|
Overall Study
Patient/guardian decision
|
1
|
1
|
1
|
Baseline Characteristics
3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study
Baseline characteristics by cohort
| Measure |
From Study 2210 (N=56)
n=56 Participants
Follow up from feeder study NCT01183169
|
From Study 2301 (N=36)
n=36 Participants
Follow up from withdrawn feeder study NCT01318694
|
Study 2211 - Overall (N=13)
n=13 Participants
Follow up from feeder study NCT01215643
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 9.86 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 10.57 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 7.88 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 10.06 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
40 participants
n=5 Participants
|
24 participants
n=7 Participants
|
6 participants
n=5 Participants
|
70 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
6 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
BMI
|
26.35 kg/m^2
STANDARD_DEVIATION 3.76 • n=5 Participants
|
25.54 kg/m^2
STANDARD_DEVIATION 4.08 • n=7 Participants
|
26.24 kg/m^2
STANDARD_DEVIATION 4.12 • n=5 Participants
|
26.06 kg/m^2
STANDARD_DEVIATION 3.89 • n=4 Participants
|
|
Baseline HCV RNA Load (log10 IU/mL)
|
6.32 log10 IU/mL
STANDARD_DEVIATION 1.3375 • n=5 Participants
|
6.19 log10 IU/mL
STANDARD_DEVIATION 0.5171 • n=7 Participants
|
6.17 log10 IU/mL
STANDARD_DEVIATION 1.1974 • n=5 Participants
|
6.26 log10 IU/mL
STANDARD_DEVIATION 1.0959 • n=4 Participants
|
PRIMARY outcome
Timeframe: 27 monthsPopulation: 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
Persistence of resistance associated variants
Outcome measures
| Measure |
All Arms
n=105 Participants
All participants in study
|
|---|---|
|
HCV RNA Sequencing
|
4 Number of particiants
|
SECONDARY outcome
Timeframe: 27 monthsPopulation: 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
Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 27 monthsPopulation: 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
Changes in liver function and disease over time
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 27 monthsPopulation: 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
Development of hepatocellular carcinoma (HCC)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 27 monthsPopulation: 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
Safety over time of previous alisporivir exposure
Outcome measures
Outcome data not reported
Adverse Events
A2210
A2301
A2211 IFN-free
A2211 Overall
Serious adverse events
| Measure |
A2210
n=53 participants at risk
From Study A2210 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set)
|
A2301
n=33 participants at risk
From Study A2301 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set)
|
A2211 IFN-free
n=6 participants at risk
From Study A2211 IFN-free (subset of Study 2211 overall)
|
A2211 Overall
n=12 participants at risk
From Study A2211 Overall (1 patient did not receive alisporivir in the feeder study and was excluded from Safety Set)
|
|---|---|---|---|---|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/6
|
0.00%
0/12
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/6
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/6
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATOCELLULAR CARCINOMA
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/6
|
0.00%
0/12
|
Other adverse events
| Measure |
A2210
n=53 participants at risk
From Study A2210 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set)
|
A2301
n=33 participants at risk
From Study A2301 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set)
|
A2211 IFN-free
n=6 participants at risk
From Study A2211 IFN-free (subset of Study 2211 overall)
|
A2211 Overall
n=12 participants at risk
From Study A2211 Overall (1 patient did not receive alisporivir in the feeder study and was excluded from Safety Set)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/6
|
8.3%
1/12
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
1.9%
1/53
|
3.0%
1/33
|
16.7%
1/6
|
16.7%
2/12
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/6
|
8.3%
1/12
|
|
Investigations
TOTAL BILE ACIDS INCREASED
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/6
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/53
|
0.00%
0/33
|
16.7%
1/6
|
8.3%
1/12
|
Additional Information
Study Director
Novartis
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Publications from a single site are postponed until publication of the pooled clinical trial data (i.e., data from all sites) or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER