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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004653-31 | EudraCT Number |
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This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alisporivir | Experimental | ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alisporivir | Drug | ALV 200 mg soft gel capsules administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12) | SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment. | 12 weeks posttreatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) | SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment. | 24 weeks posttreatment |
| Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD) |
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Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85054 | United States | ||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alisporivir | Alisporivir (ALV) 400 mg twice daily (BID), with peginterferon alfa-2a (PEG) and ribavirin (RBV) for 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Peginterferon alfa-2a | Drug | PEG 180 μg administered via subcutaneous (s.c.) injection once weekly |
|
|
| Ribavirin | Drug | RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose |
|
|
Level of detection (LOD) was defined as 10 IU/mL |
| 12 weeks posttreatment |
| Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events | 48 weeks |
| Bakersfield |
| California |
| 93301 |
| United States |
| Novartis Investigative Site | Los Angeles | California | 90033 | United States |
| Novartis Investigative Site | Palo Alto | California | 95128 | United States |
| Novartis Investigative Site | Sacramento | California | 95817 | United States |
| Novartis Investigative Site | San Diego | California | 92114 | United States |
| Novartis Investigative Site | San Diego | California | 92128 | United States |
| Novartis Investigative Site | Ventura | California | 93003 | United States |
| Novartis Investigational site | Bradenton | Florida | 34209 | United States |
| Novartis Investigative Site | Bradenton | Florida | 34209 | United States |
| Novartis Investigative Site | Miami | Florida | 33136 | United States |
| Novartis Investigative Site | Wellington | Florida | 33414 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60611 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21229 | United States |
| Novartis Investigative Site | Brockton | Massachusetts | 02302 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55404 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63110 | United States |
| Novartis Investigative Site | New York | New York | 10021 | United States |
| Novartis Investigative Site | New York | New York | 10029 | United States |
| Novartis Investigative Site | New York | New York | 10032 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45267 | United States |
| Novartis Investigative Site | Providence | Rhode Island | 02905 | United States |
| Novartis Investigative Site | Arlington | Texas | 76012 | United States |
| Novartis Investigative Site | Dallas | Texas | 75246 | United States |
| Novartis Investigative Site | Alexandria | Virginia | 22306 | United States |
| Novartis Investigative Site | Newport News | Virginia | 23602 | United States |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 1J4 | Canada |
| Novartis Investigative Site | Vancouver | British Columbia | v6z 2k5 | Canada |
| Novartis Investigative Site | Clichy | 92110 | France |
| Novartis Investigative Site | Créteil | 94000 | France |
| Novartis Investigative Site | Paris | 75006 | France |
| Novartis Investigational Site | Berlin | 10969 | Germany |
| Novartis Investigative Site | Berlin | 10969 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigational Site | Cologne | 50924 | Germany |
| Novartis Investigative Site | Cologne | 50924 | Germany |
| Novartis Investigative Site | Düsseldorf | 40225 | Germany |
| Novartis Investigative Site | Düsseldorf | 40237 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigational Site | Frieburg | 79106 | Germany |
| Novartis Investigative Site | Hamburg | 20099 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Kiel | 24146 | Germany |
| Novartis Investigational Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Milan | MI | 20122 | Italy |
| Novartis Investigative Site | Modena | MO | 41124 | Italy |
| Novartis Investigative Site | Palermo | PA | 90127 | Italy |
| Novartis Investigative Site | Padova | PD | 35128 | Italy |
| Novartis Investigative Site | Roma | RM | 00161 | Italy |
| Novartis Investigative Site | Torino | TO | 10126 | Italy |
| Novartis Investigative Site | Bologna | 40138 | Italy |
| Novartis Investigative Site | San Juan | 00909 | Puerto Rico |
| Novartis Investigative Site | Barcelona | Barcelona | 08035 | Spain |
| Novartis Investigative Site | Majadanonda | Madrid | 28222 | Spain |
| Novartis Investigative Site | London | NW3 3QG | United Kingdom |
| Novartis Investigative Site | London | SE5 9RS | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
All enrolled patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Alisporivir | ALV 400 mg BID with PEG and RBV for 48 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| 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 Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12) | SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment. | The study was terminated before the outcome measure time point. | Posted | 12 weeks posttreatment |
|
| |||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) | SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment. | The study was terminated before the outcome measure time point. | Posted | 24 weeks posttreatment |
|
| |||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD) | Level of detection (LOD) was defined as 10 IU/mL | The study was terminated before the outcome measure time point. | Posted | 12 weeks posttreatment |
|
| |||||||||||||||||||
| Secondary | Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events | The study was terminated before the outcome measure time point. | Posted | 48 weeks |
|
|
Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
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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 | Alisporivir | ALV 400 mg BID with PEG and RBV for 48 weeks. | 0 | 6 | 5 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Skin Fissures | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Seborrhoeic Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Sleep Disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
Due to early termination of the study, none of the planned outcome measures could be evaluated.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Research and Development | Debiopharm International S.A. | 4121 321 01 11 | info-international@debiopharm.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| 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 |
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| ID | Term |
|---|---|
| C499715 | alisporivir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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