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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006132-24 |
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Study was prematurely terminated.
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Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow up from feeder studies | Other | Follow up arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Previous treatment in DEB025 study | Drug | Follow-up after DEB025 active study |
|
| Measure | Description | Time Frame |
|---|---|---|
| HCV RNA Sequencing | Persistence of resistance associated variants | 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Parameters as Measured by HCV RNA Sequencing | Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro | 27 months |
| Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | San Diego | California | 92101 | United States | ||
| Novartis Investigative Site |
terminated
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| ID | Title | Description |
|---|---|---|
| FG000 | From Study 2210 (N=56) | Follow up from feeder study NCT01183169 |
| FG001 | From Study 2301 (N=36) | Follow up from withdrawn feeder study NCT01318694 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Changes in liver function and disease over time
| 27 months |
| Safety Parameters as Measured by Liver UltraSound and Lab Parameters | Development of hepatocellular carcinoma (HCC) | 27 months |
| Safety Parameters | Safety over time of previous alisporivir exposure | 27 months |
| Ventura |
| California |
| 93003 |
| United States |
| Novartis Investigative Site | Honolulu | Hawaii | 96814 | United States |
| Novartis Investigative Site | Springfield | Illinois | 62703 | United States |
| Novartis Investigative Site | Arlington | Texas | 76012 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78215 | United States |
| Novartis Investigative Site | Westmead | New South Wales | 2145 | Australia |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Torono | Ontario | M5G 2C4 | Canada |
| Novartis Investigative Site | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Hamburg | 20099 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Kiel | 24146 | Germany |
| Novartis Investigative Site | Budapest | 1097 | Hungary |
| Novartis Investigative Site | Mumbai | Maharashtra | 400 036 | India |
| Novartis Investigative Site | Parma | PR | 43100 | Italy |
| Novartis Investigative Site | Pavia | PV | 27100 | Italy |
| Novartis Investigative Site | Roma | RM | 00161 | Italy |
| Novartis Investigative Site | Torino | TO | 10126 | Italy |
| Novartis Investigative Site | Bialystok | 15-540 | Poland |
| Novartis Investigative Site | Warsaw | 01-201 | Poland |
| Novartis Investigative Site | San Juan | 00909 | Puerto Rico |
| Novartis Investigative Site | Bucharest | District 1 | 050524 | Romania |
| Novartis Investigative Site | Bucharest | District 3 | 030317 | Romania |
| Novartis Investigative Site | Bucharest | 020125 | Romania |
| Novartis Investigative Site | Bucharest | 021105 | Romania |
| Novartis Investigative Site | Iași | 700506 | Romania |
| Novartis Investigative Site | Busan | 49241 | South Korea |
| Novartis Investigative Site | Pusan | 614-735 | South Korea |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Douliu | 640 | Taiwan |
| Novartis Investigative Site | Kaohsiung City | 80756 | Taiwan |
| Novartis Investigative Site | Kaohsiung City | 83301 | Taiwan |
| Novartis Investigative Site | Linkou District | 33305 | Taiwan |
| Novartis Investigative Site | Taichung | 40447 | Taiwan |
| Novartis Investigative Site | Songkhla | 90110 | Thailand |
| Novartis Investigative Site | Ho Chi Minh City | Vietnam |
| FG002 | From Study 2211 - Overall (N=13) | Follow up from feeder study NCT01215643 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | From Study 2210 (N=56) | Follow up from feeder study NCT01183169 |
| BG001 | From Study 2301 (N=36) | Follow up from withdrawn feeder study NCT01318694 |
| BG002 | Study 2211 - Overall (N=13) | Follow up from feeder study NCT01215643 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Baseline HCV RNA Load (log10 IU/mL) | Mean | Standard Deviation | log10 IU/mL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HCV RNA Sequencing | Persistence of resistance associated variants | 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 | Posted | Number | Number of particiants | 27 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Safety Parameters as Measured by HCV RNA Sequencing | Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro | 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 | Posted | 27 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters | Changes in liver function and disease over time | 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 | Posted | 27 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Safety Parameters as Measured by Liver UltraSound and Lab Parameters | Development of hepatocellular carcinoma (HCC) | 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 | Posted | 27 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Safety Parameters | Safety over time of previous alisporivir exposure | 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 | Posted | 27 months |
|
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A2210 | From Study A2210 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set) | 3 | 53 | 1 | 53 | ||
| EG001 | A2301 | From Study A2301 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set) | 0 | 33 | 1 | 33 | ||
| EG002 | A2211 IFN-free | From Study A2211 IFN-free (subset of Study 2211 overall) | 0 | 6 | 2 | 6 | ||
| EG003 | A2211 Overall | From Study A2211 Overall (1 patient did not receive alisporivir in the feeder study and was excluded from Safety Set) | 0 | 12 | 4 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| HEPATOCELLULAR CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| BLOOD TRIGLYCERIDES INCREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| TOTAL BILE ACIDS INCREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
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
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | +41613241111 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
|
| Black |
|
| Asian |
|
| Native American |
|
| Pacific Islander |
|
| Other |
|