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The aim of this exploratory study is to evaluate the rejection rate in patients treated with cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h monitoring. In addition, this study will assess the safety of this treatment regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine (Sandimmun®) | Experimental | Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine (Sandimmun® i.v.) | Drug | Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation | Number of patients with biopsy proven acute rejection (BPAR) within 3 months after post de novo liver transplantation. In all suspected rejection episodes an allograft biopsy was performed within a 48 hour period of initiation of an anti-rejection therapy. A designated pathologist graded the biopsies according to the Banff criteria into mild, moderate or severe BPAR. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation | The secondary efficacy endpoints included: the incidence of BPAR at 6 months; the incidence of treated acute rejection (TAR) / steroid-resistant acute rejection at 3 and 6 months; the incidence of BPAR with moderate/severe histological grading at 3 and 6 months; time to the first BPAR, the first TAR / steroid-resistant acute rejection and BPAR with moderate/severe histological grading; patient death at 3 and 6 months; and graft loss at 3 and 6 months. |
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Inclusion Criteria
Exclusion Criteria
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigational Site | Various Cities | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyclosporine (Sandimmun®) | Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyclosporine (Sandimmun®) | Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation | Number of patients with biopsy proven acute rejection (BPAR) within 3 months after post de novo liver transplantation. In all suspected rejection episodes an allograft biopsy was performed within a 48 hour period of initiation of an anti-rejection therapy. A designated pathologist graded the biopsies according to the Banff criteria into mild, moderate or severe BPAR. | Intention to treat (ITT) population | Posted | Number | Participants | 3 months |
|
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34 of the 34 study participants received treatment with Cyclosporine (Sandimmun® i.v.). Only 29 of the 34 participants received treatment with Cyclosporine (Sandimmun® Optoral).
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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 | Cyclosporine (Sandimmun® i.v.) | Cyclosporine (Sandimmun®) intravenous (i.v) given 2 times daily as an infusion over a four hour period staring at a dose of 2 X 200 mg/day and continuing for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
|
| Cyclosporine (Sandimmun® Optoral) | Drug | Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels. |
|
|
| 3 or 6 months after transplantation |
| no longer requires study drug |
|
| Death |
|
| Graft Loss |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation | The secondary efficacy endpoints included: the incidence of BPAR at 6 months; the incidence of treated acute rejection (TAR) / steroid-resistant acute rejection at 3 and 6 months; the incidence of BPAR with moderate/severe histological grading at 3 and 6 months; time to the first BPAR, the first TAR / steroid-resistant acute rejection and BPAR with moderate/severe histological grading; patient death at 3 and 6 months; and graft loss at 3 and 6 months. | Intention-to-treat (ITT) population. | Posted | Number | Participants | 3 or 6 months after transplantation |
|
|
|
| 18 |
| 34 |
| 34 |
| 34 |
| EG001 | Cyclosporine (Sandimmun® Optoral) | Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels. | 14 | 29 | 29 | 29 |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| PERITONEAL HAEMATOMA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| HERNIA | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| MULTI-ORGAN FAILURE | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| SYSTEMIC LEAKAGE | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| BILE DUCT OBSTRUCTION | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| BILE DUCT STENOSIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| BILIARY ISCHAEMIA | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| CHOLANGITIS SCLEROSING | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| GRAFT VERSUS HOST DISEASE | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
|
| LIVER TRANSPLANT REJECTION | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
|
| CYTOMEGALOVIRUS COLITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| DIARRHOEA INFECTIOUS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| HEPATITIS B | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| ABDOMINAL WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| COMPLICATIONS OF TRANSPLANTED LIVER | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| HEPATIC HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| SEROMA | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| FIBRINOLYSIS INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| HEPATITIS C VIRUS | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| NEUROENDOCRINE TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| ANURIA | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| HAEMORRHAGE | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| COAGULOPATHY | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| ARRHYTHMIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| BRADYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| TACHYARRHYTHMIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| ANTITHROMBIN III DEFICIENCY | Congenital, familial and genetic disorders | MedDRA 10.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| PERITONITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| IMPAIRED HEALING | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| MALAISE | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| OEDEMA | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| PUNCTURE SITE PAIN | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| CHOLESTASIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| ABDOMINAL INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| CANDIDIASIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| FUNGAL INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| HERPES SIMPLEX | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| SYSTEMIC CANDIDA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| WOUND INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| ANAEMIA POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| COMPLICATIONS OF TRANSPLANTED LIVER | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| OPERATIVE HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| PROCEDURAL HYPOTENSION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| TRANSAMINASES INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| FOLATE DEFICIENCY | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPERNATRAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| VITAMIN K DEFICIENCY | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| SLEEP DISORDER | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| OLIGURIA | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| SCAR PAIN | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| HAEMATOMA | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Patients with TAR : YES |
|
| Patients with TAR : NO |
|
| Patients w/ steroid-resistant acute rejection:YES |
|
| Patients w/ steroid-resistant acute rejection:NO |
|
| BPAR w/ moderate/severe histological grading:YES |
|
| BPAR w/ moderate/severe histological grading:NO |
|
| Occurence of Death : YES |
|
| Occurence of Death : NO |
|
| Occurence of Graft loss : YES |
|
| Occurence of Graft loss : NO |
|