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This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alisporivir | Experimental | At the time of partial clinical hold, participants randomized to original treatment arms A and B (Alisporivir triple therapy arms with Peginterferon alfa-2a and Ribavirin) discontinued alisporivir treatment immediately while continuing their treatments with the other two therapies. These participants were combined into the same arm because they received the same dose of alisporivir 400 mg twice per day (BID) for the same duration. Amendment 1 offered them the opportunity to continue in the study receiving boceprevir triple therapy. |
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| Boceprevir | Active Comparator | Participants randomized to boceprevir triple therapy with Peginterferon alfa-2a and Ribavirin (the original treatment arm C). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alisporivir | Drug | ALV 200 mg soft gel capsules administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events | within 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Emergence of Resistant Mutations | within 48 weeks | |
| Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24) | SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment. |
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Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigational Site | Beverly Hills | California | 90211 | United States | ||
| Novartis Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alisporivir | Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1. |
| FG001 | Boceprevir |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Boceprevir | Drug | BOC 800 mg (4 x 200 mg soft gel capsules) administered orally |
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| Peginterferon alfa-2a | Drug | PEG 180 μg administered via subcutaneous (s.c.) injection once weekly |
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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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| 24 weeks post-treatment |
| Baltimore |
| Maryland |
| 21229 |
| United States |
Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
| FG002 | PEGinf + RBV | Participants who received ALV in Treatment Period 1 were put on clinical hold but continued receiving PEGinf and RBV for 4 weeks, after which they switched to BOC triple therapy in Treatment Period 2. |
| FG003 | No Intervention | Participants who had an End of Treatment Response (ETR) were followed-up for 24 weeks after the last dose of BOC triple therapy (in Treatment Period 2) and participants who did not respond for any reason or discontinued the treatment early were followed-up for 12 weeks after the last dose of BOC (in Treatment Period 2). |
| COMPLETED |
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| NOT COMPLETED |
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| Clinical Hold |
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| Treatment Period 2 |
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| Follow-up |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Participants | Analysis was performed on all enrolled participants. |
| 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, Categorical | Count of Participants | Participants |
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| Gender | 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 | Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events | No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point. | Posted | within 48 weeks |
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| Secondary | Percentage of Participants With Emergence of Resistant Mutations | No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point. | Posted | within 48 weeks |
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| Secondary | Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24) | SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment. | No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point. | Posted | 24 weeks post-treatment |
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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 | Adverse event (AE) occurred while taking Alisporivir + PEGinf + RBV. | 0 | 5 | 5 | 5 | ||
| EG001 | Boceprevir | AE occurred while taking Boceprevir + PEGinf + RBV. | 1 | 8 | 8 | 8 | ||
| EG002 | PEGinf + RBV | AE occurred while taking only PEGinf + RBV. | 0 | 8 | 4 | 8 | ||
| EG003 | No Intervention | AE was discovered while taking no intervention. | 0 | 6 | 1 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus Generalised | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Influenza Like Illness | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Disturbance in Attention | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA 16.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Haematocrit Decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Haemoglobin Decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Gastric Ulcer | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Gastroenteritis Viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Sleep Disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Libido Decreased | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Hot Flush | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Pharyngitis Streptococcal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Seasonal Allergy | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
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| Ageusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Oral Candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Blood Creatinine Increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Confusional State | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Memory Impairment | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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Due to the early termination of study enrollment and discontinuation of alisporivir treatment, Amendment 1 changed the number of study arms to 2, combining Arms A and B, and none of the planned outcome measures could be evaluated.
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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 |
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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