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3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study

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ClinicalTrials.gov Identifier: NCT02465203
Recruitment Status : Terminated (Study was prematurely terminated.)
First Posted : June 8, 2015
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Hepatitis C, Chronic
Intervention Drug: Previous treatment in DEB025 study
Enrollment 105
Recruitment Details  
Pre-assignment Details  
Arm/Group Title From Study 2210 (N=56) From Study 2301 (N=36) From Study 2211 - Overall (N=13)
Hide Arm/Group Description Follow up from feeder study NCT01183169 Follow up from withdrawn feeder study NCT01318694 Follow up from feeder study NCT01215643
Period Title: Overall Study
Started 56 36 13
Completed 0 0 0
Not Completed 56 36 13
Reason Not Completed
Protocol Violation             1             1             1
Study terminated by sponsor             50             34             11
New therapy for study indication             4             0             0
Patient/guardian decision             1             1             1
Arm/Group Title From Study 2210 (N=56) From Study 2301 (N=36) Study 2211 - Overall (N=13) Total
Hide Arm/Group Description Follow up from feeder study NCT01183169 Follow up from withdrawn feeder study NCT01318694 Follow up from feeder study NCT01215643 Total of all reporting groups
Overall Number of Baseline Participants 56 36 13 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 36 participants 13 participants 105 participants
52.7  (9.86) 53.8  (10.57) 46.5  (7.88) 52.3  (10.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 36 participants 13 participants 105 participants
Female
23
  41.1%
22
  61.1%
4
  30.8%
49
  46.7%
Male
33
  58.9%
14
  38.9%
9
  69.2%
56
  53.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 36 participants 13 participants 105 participants
Caucasian 40 24 6 70
Black 3 0 1 4
Asian 12 12 6 30
Native American 0 0 0 0
Pacific Islander 0 0 0 0
Other 1 0 0 1
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 56 participants 36 participants 13 participants 105 participants
26.35  (3.76) 25.54  (4.08) 26.24  (4.12) 26.06  (3.89)
[1]
Measure Description: Body Mass Index
Baseline HCV RNA Load (log10 IU/mL)  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 56 participants 36 participants 13 participants 105 participants
6.32  (1.3375) 6.19  (0.5171) 6.17  (1.1974) 6.26  (1.0959)
1.Primary Outcome
Title HCV RNA Sequencing
Hide Description Persistence of resistance associated variants
Time Frame 27 months
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title All Arms
Hide Arm/Group Description:
All participants in study
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Number of particiants
4
2.Secondary Outcome
Title Safety Parameters as Measured by HCV RNA Sequencing
Hide Description Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro
Time Frame 27 months
Hide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title All Arms
Hide Arm/Group Description:
All participants in study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters
Hide Description Changes in liver function and disease over time
Time Frame 27 months
Hide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title All Arms
Hide Arm/Group Description:
All participants in study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Safety Parameters as Measured by Liver UltraSound and Lab Parameters
Hide Description Development of hepatocellular carcinoma (HCC)
Time Frame 27 months
Hide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title All Arms
Hide Arm/Group Description:
All participants in study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Safety Parameters
Hide Description Safety over time of previous alisporivir exposure
Time Frame 27 months
Hide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title All Arms
Hide Arm/Group Description:
All participants in study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A2210 A2301 A2211 IFN-free A2211 Overall
Hide Arm/Group Description From Study A2210 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set) From Study A2301 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set) From Study A2211 IFN-free (subset of Study 2211 overall) From Study A2211 Overall (1 patient did not receive alisporivir in the feeder study and was excluded from Safety Set)
All-Cause Mortality
A2210 A2301 A2211 IFN-free A2211 Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A2210 A2301 A2211 IFN-free A2211 Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/53 (5.66%)   0/33 (0.00%)   0/6 (0.00%)   0/12 (0.00%) 
Hepatobiliary disorders         
CHOLECYSTITIS  1  1/53 (1.89%)  0/33 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
CHOLELITHIASIS  1  1/53 (1.89%)  0/33 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Injury, poisoning and procedural complications         
HAND FRACTURE  1  1/53 (1.89%)  0/33 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
HEPATOCELLULAR CARCINOMA  1  1/53 (1.89%)  0/33 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A2210 A2301 A2211 IFN-free A2211 Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/53 (1.89%)   1/33 (3.03%)   2/6 (33.33%)   4/12 (33.33%) 
Gastrointestinal disorders         
ABDOMINAL PAIN UPPER  1  0/53 (0.00%)  0/33 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Hepatobiliary disorders         
HEPATIC STEATOSIS  1  1/53 (1.89%)  1/33 (3.03%)  1/6 (16.67%)  2/12 (16.67%) 
Investigations         
BLOOD TRIGLYCERIDES INCREASED  1  0/53 (0.00%)  0/33 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
TOTAL BILE ACIDS INCREASED  1  0/53 (0.00%)  0/33 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders         
NECK PAIN  1  0/53 (0.00%)  0/33 (0.00%)  1/6 (16.67%)  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
There is no statistical hypothesis for this single-arm uncontrolled terminated study. Study was powered for efficacy of 650 participants and only 105 were randomized
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis
Phone: +41613241111
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02465203     History of Changes
Other Study ID Numbers: CDEB025A2313
2011-006132-24
First Submitted: March 17, 2015
First Posted: June 8, 2015
Results First Submitted: July 15, 2015
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018