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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006131-38 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| From Study 2210 | Experimental | All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study. |
|
| From Study 2301 | Experimental | All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study. |
|
| From Study 2211 | Experimental | All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alisporivir | Drug | Intervention of interest; follow-up after ALV-active study |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at Week 48 |
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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 | La Jolla | California | 92037 | United States | ||
| Novartis Investigative Site |
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.
The study was conducted in 127 centers across 22 countries globally.
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| ID | Title | Description |
|---|---|---|
| FG000 | From Study 2210 | All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study. |
| FG001 | From Study 2301 | All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| San Diego |
| California |
| 92101 |
| United States |
| Novartis Investigative Site | Ventura | California | 93003 | United States |
| Novartis Investigative Site | Bradenton | Florida | 34209 | United States |
| Novartis Investigative Site | Honolulu | Hawaii | 96814 | United States |
| Novartis Investigative Site | Springfield | Illinois | 62703 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46237 | United States |
| Novartis Investigative Site | Arlington | Texas | 76012 | United States |
| Novartis Investigative Site | Dallas | Texas | 75246-2096 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78215 | United States |
| Novartis Investigative Site | Salt Lake City | Utah | 84124 | United States |
| Novartis Investigative Site | Buenos Aires | Buenos Aires | C1125ABE | Argentina |
| Novartis Investigative Site | Buenos Aires | Buenos Aires | C1405BCK | Argentina |
| Novartis Investigative Site | Kingswood | New South Wales | 2747 | Australia |
| Novartis Investigative Site | Kogarah | New South Wales | 2217 | Australia |
| Novartis Investigative Site | Westmead | New South Wales | 2145 | Australia |
| Novartis Investigative Site | Greenslopes | Queensland | 4120 | Australia |
| Novartis Investigative Site | Fitzroy | Victoria | 3065 | Australia |
| Novartis Investigative Site | Ghent | 9000 | Belgium |
| Novartis Investigative Site | Calgary | Alberta | T2N 4N1 | Canada |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 1J4 | Canada |
| Novartis Investigative Site | Vancouver | British Columbia | v6z 2k5 | Canada |
| Novartis Investigative Site | Torono | Ontario | M5G 2C4 | Canada |
| Novartis Investigative Site | Clichy | 92110 | France |
| Novartis Investigative Site | Créteil | 94010 | France |
| Novartis Investigative Site | Lyon | 69317 | France |
| Novartis Investigative Site | Nice | 06202 | France |
| Novartis Investigative Site | Paris | 75014 | France |
| Novartis Investigative Site | Berlin | 10969 | Germany |
| Novartis Investigative Site | Cologne | 50937 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | 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 | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Hong Kong | Hong Kong | Hong Kong |
| Novartis Investigative Site | Békéscsaba | H-5600 | Hungary |
| Novartis Investigative Site | Budapest | 1083 | Hungary |
| Novartis Investigative Site | Budapest | 1097 | Hungary |
| Novartis Investigative Site | Budapest | 1126 | Hungary |
| Novartis Investigative Site | Debrecen | 4032 | Hungary |
| Novartis Investigative Site | Kaposvár | 7400 | Hungary |
| Novartis Investigative Site | Pécs | 7624 | Hungary |
| Novartis Investigative Site | Székesfehérvár | 8000 | Hungary |
| Novartis Investigative Site | Hyderabad | Andhra Pradesh | 500012 | India |
| Novartis Investigative Site | Mumbai | Maharashtra | 400012 | India |
| Novartis Investigative Site | Delhi | National Capital Territory of Delhi | 110070 | India |
| Novartis Investigative Site | Ludhiana | Punjab | 141001 | India |
| Novartis Investigative Site | Bologna | BO | 40138 | Italy |
| Novartis Investigative Site | Brescia | BS | 25123 | Italy |
| Novartis Investigative Site | Milan | MI | 20121 | Italy |
| Novartis Investigative Site | Milan | MI | 20122 | Italy |
| Novartis Investigative Site | Milan | MI | 20162 | Italy |
| Novartis Investigative Site | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Palermo | PA | 90127 | Italy |
| Novartis Investigative Site | Parma | PR | 43100 | Italy |
| Novartis Investigative Site | Pavia | PV | 27100 | Italy |
| Novartis Investigative Site | Roma | RM | 00133 | Italy |
| Novartis Investigative Site | Roma | RM | 00161 | Italy |
| Novartis Investigative Site | Torino | TO | 10126 | Italy |
| Novartis Investigative Site | Bologna | 40138 | Italy |
| Novartis Investigative Site | Naples | 80135 | Italy |
| Novartis Investigative Site | Mexico City | Mexico City | 14000 | Mexico |
| Novartis Investigative Site | Monterrey | Nuevo León | 64020 | Mexico |
| Novartis Investigative Site | Bialystok | 15-540 | Poland |
| Novartis Investigative Site | Bydgoszcz | 85-030 | Poland |
| Novartis Investigative Site | Lódz | 91-347 | Poland |
| Novartis Investigative Site | Warsaw | 01-201 | Poland |
| Novartis Investigative Site | Zawiercie | 42-400 | Poland |
| Novartis Investigative Site | Bucharest | 020125 | Romania |
| Novartis Investigative Site | Bucharest | 021105 | Romania |
| Novartis Investigative Site | Bucharest | 030317 | Romania |
| Novartis Investigative Site | Bucharest | 050524 | Romania |
| Novartis Investigative Site | Craiova | 200515 | Romania |
| Novartis Investigative Site | Iași | 700506 | Romania |
| Novartis Investigative Site | Iași | Romania |
| Novartis Investigative Site | Moscow | 111123 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197376 | Russia |
| Novartis Investigative Site | Busan | Busan | 602-739 | South Korea |
| Novartis Investigative Site | Seongnam-si | Gyeonggi-do | 463-712 | South Korea |
| Novartis Investigative Site | Yangsan | Gyeongsangnam-do | 626-770 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 03722 | South Korea |
| Novartis Investigative Site | Busan | 602-715 | South Korea |
| Novartis Investigative Site | Incheon | 22332 | South Korea |
| Novartis Investigative Site | Pusan | 614-735 | South Korea |
| Novartis Investigative Site | Seville | Andalusia | 41014 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08003 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Majadahonda | Madrid | 28222 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46014 | Spain |
| Novartis Investigative Site | Chiayi City | Taiwan | 600 | Taiwan |
| Novartis Investigative Site | Douliu | 640 | Taiwan |
| Novartis Investigative Site | Kaohsiung City | 807 | Taiwan |
| Novartis Investigative Site | Keelung | 20401 | Taiwan |
| Novartis Investigative Site | Linkou District | 33305 | Taiwan |
| Novartis Investigative Site | Niaosong Township | 83301 | Taiwan |
| Novartis Investigative Site | Taichung | 40447 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Taipei | 112 | Taiwan |
| Novartis Investigative Site | Bangkok | 10700 | Thailand |
| Novartis Investigative Site | Chiang Mai | 50200 | Thailand |
| Novartis Investigative Site | Khon Kaen | 40002 | Thailand |
| Novartis Investigative Site | Songkhla | 90110 | Thailand |
| Novartis Investigative Site | Fatih / Istanbul | 34098 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35040 | Turkey (Türkiye) |
| Novartis Investigative Site | Birmingham | B15 2TT | United Kingdom |
| Novartis Investigative Site | Glasgow - Scotland | G12 OYN | United Kingdom |
| Novartis Investigative Site | London | E1 1BB | United Kingdom |
| Novartis Investigative Site | London | SE5 9RS | United Kingdom |
| Novartis Investigative Site | London | SW17 0QT | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Novartis Investigative Site | Nottingham | NG7 2UH | United Kingdom |
| Novartis Investigative Site | Plymouth | PL6 8DH | United Kingdom |
| Novartis Investigative Site | Hanoi | 100000 | Vietnam |
| Novartis Investigative Site | Hanoi | Vietnam |
| Novartis Investigative Site | Ho Chi Minh City | Vietnam |
| FG002 | From Study 2211 | All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. |
| COMPLETED |
|
| NOT COMPLETED |
|
The Safety Set, defined as including all patients who had at least one safety observation (adverse event (AE), vital sign and/or laboratory assessment), unless excluded due to protocol deviations.
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| ID | Title | Description |
|---|---|---|
| BG000 | From Study 2210 | All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study. |
| BG001 | From Study 2301 | All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study. |
| BG002 | From Study 2211 | All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. |
| 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 |
|
| 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 | Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 | 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. | Posted | Number | percentage of participants | up to 120 Weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | percentage of participants | at Week 48 |
|
Up to 48 weeks
Non-serious adverse events did not reach the 5% reporting threshold.
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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 | From Study 2210 | All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study. | 7 | 164 | 0 | 164 | ||
| EG001 | From Study 2301 | All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study. | 8 | 397 | 0 | 397 | ||
| EG002 | From Study 2211 IFN-free | Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study. | 1 | 54 | 0 | 54 | ||
| EG003 | From Study 2211 Overall | All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. | 3 | 162 | 0 | 162 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Herpes simplex meningitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Osteomyelitis acute | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Collagen disorder | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Clinical Research & Development | Debiopharm International, S.A. | 4121 321 01 11 | info-international@debiopharm.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C499715 | alisporivir |
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| Male |
|
| Week 24 (n=148,346,49,148) |
|
| Week 48 (n=146,337,46,140) |
|
| Week 96 (n=7,0,36,90) |
|
| Week 120 (n=0,0,1,3) |
|
| Overall (n=161,383,53,160) |
|
All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. |
|
|