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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003751-38 | EudraCT Number |
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The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alisporivir 300 mg BID | Experimental | Alisporivir (ALV) 300 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication |
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| Alisporivir 400 mg BID | Experimental | ALV 400 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alisporivir | Drug | ALV 100 and 200 mg soft gel capsules administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12 | The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12. | Baseline, Week 12 |
| Change From Baseline in Alanine Aminotransferase (ALT) at Week 12 | ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment | SVR is defined as HCV RNA less than the lower limit of quantification (LLOQ), i.e., <15 IU/mL, at 4 weeks (SVR4), 12 weeks (SVR12), and 24 weeks (SVR24) after treatment, respectively. | Up to 24 weeks posttreatment |
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Inclusion Criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bakersfield | California | 93301 | United States | ||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alisporivir 300 mg BID | Alisporivir (ALV) 300 mg twice per day (BID) with ribavirin (RBV) for up to 24 weeks. |
| FG001 | Alisporivir 400 mg BID | ALV 400 mg BID with RBV for up to 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 |
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| Percentage of Participants With Extended Rapid Virologic Response |
Extended rapid virologic response (eRVR) was defined as serum HCV RNA < LLOQ after 2 weeks of treatment |
| 2 weeks |
| Percentage of Participants With Rapid Virologic Response (RVR) | eRVR was defined as serum HCV RNA < LLOQ after 4 weeks of treatment | 4 weeks |
| Percentage of Participants With End of Treatment Response (ETR) | ETR was defined as serum HCV RNA < LLOQ at treatment end (completed or prematurely discontinued). | Up to 24 weeks |
| Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | ALT is an enzyme found mostly in the cells of the liver and kidney. When the liver is damaged, ALT is released into the blood. This makes ALT a common test for liver damage, because higher ALT levels may indicate more liver damage. ALT upper limit of normal is commonly considered to be 40 international units per liter (IU/L), so abnormal ALT is above 40 IU/L. | Up to 24 weeks |
| Lancaster |
| California |
| 93534 |
| United States |
| Novartis Investigative Site | San Diego | California | 92114 | United States |
| Novartis Investigative Site | San Diego | California | 92128 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63110 | 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 | Newport News | Virginia | 23602 | United States |
| Novartis Investigative Site | Seattle | Washington | 98101 | United States |
| Novartis Investigative Site | Seattle | Washington | 98104 | United States |
| 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 |
| Completed at Week 12 |
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| Completed at Week 24 |
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| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set, defined as all participants who were correctly randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alisporivir 300 mg BID | ALV 300 mg BID with RBV for up to 24 weeks. |
| BG001 | Alisporivir 400 mg BID | ALV 400 mg BID with RBV for up to 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12 | The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12. | Full Analysis Set | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline, Week 12 |
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| Primary | Change From Baseline in Alanine Aminotransferase (ALT) at Week 12 | ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage. | Participants in the safety set with available data at the given time point | Posted | Mean | Standard Deviation | U/L | Baseline, Week 12 |
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| Secondary | Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment | SVR is defined as HCV RNA less than the lower limit of quantification (LLOQ), i.e., <15 IU/mL, at 4 weeks (SVR4), 12 weeks (SVR12), and 24 weeks (SVR24) after treatment, respectively. | Full Analysis Set | Posted | Number | percentage of participants | Up to 24 weeks posttreatment |
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| Secondary | Percentage of Participants With Extended Rapid Virologic Response | Extended rapid virologic response (eRVR) was defined as serum HCV RNA < LLOQ after 2 weeks of treatment | Full Analysis Set | Posted | Number | percentage of participants | 2 weeks |
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| Secondary | Percentage of Participants With Rapid Virologic Response (RVR) | eRVR was defined as serum HCV RNA < LLOQ after 4 weeks of treatment | Full Analysis Set | Posted | Number | percentage of participants | 4 weeks |
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| Secondary | Percentage of Participants With End of Treatment Response (ETR) | ETR was defined as serum HCV RNA < LLOQ at treatment end (completed or prematurely discontinued). | Full Analysis Set | Posted | Number | percentage of participants | Up to 24 weeks |
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| Secondary | Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | ALT is an enzyme found mostly in the cells of the liver and kidney. When the liver is damaged, ALT is released into the blood. This makes ALT a common test for liver damage, because higher ALT levels may indicate more liver damage. ALT upper limit of normal is commonly considered to be 40 international units per liter (IU/L), so abnormal ALT is above 40 IU/L. | Full Analysis Set | Posted | Number | percentage of participants | Up to 24 weeks |
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Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
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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 300 mg BID | ALV 300 mg BID with RBV for up to 24 weeks. | 3 | 26 | 22 | 26 | ||
| EG001 | Alisporivir 400 mg BID | ALV 400 mg BID with RBV for up to 24 weeks. | 3 | 26 | 24 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Epiglottitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Ocular icterus | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Pruritis generalised | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 17.1 | 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 |
| D008107 | Liver Diseases |
| 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 |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C499715 | alisporivir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Male |
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