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This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease. Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. For this study, each enrolled patient will be followed up for 3 years after enrollment. Patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1/new use cohort | Subjects who initiated pasireotide s.c. at time of study entry (on or after the signing of the informed consent or acknowledging an equivalent document -for example, written information- as per country regulation). |
| |
| Cohort 2/prior use cohort | Subjects who initiated pasireotide s.c. prior to study entry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasireotide | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c. | Number of pasireotide s.c related adverse events and serious adverse events, when administered as monotherapy or in combination with other therapies in patients with Cushing's disease | 3-year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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The patient population will consist of male and female patients aged 18 years or older with a diagnosis of Cushing's disease for whom surgery has failed or for whom surgery is not an option and who are treated with pasireotide s.c.
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| Name | Affiliation | Role |
|---|---|---|
| Mario MALDONADO, MD | Recordati AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Josephs Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| University of Southern California CSOM230B2410 - SC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31440946 | Derived | Manetti L, Deutschbein T, Schopohl J, Yuen KCJ, Roughton M, Kriemler-Krahn U, Tauchmanova L, Maamari R, Giordano C. Long-term safety and efficacy of subcutaneous pasireotide in patients with Cushing's disease: interim results from a long-term real-world evidence study. Pituitary. 2019 Oct;22(5):542-551. doi: 10.1007/s11102-019-00984-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 6, 2020 | Jul 15, 2024 |
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| Los Angeles |
| California |
| 90033 |
| United States |
| Massachusetts General Hospital SC - SOM230B2410 | Boston | Massachusetts | 02114 | United States |
| Ohio State University SC - SOM230B2410 | Columbus | Ohio | 43210 | United States |
| Endocrinology Services | Bend | Oregon | 97702 | United States |
| Allegheny Endocrinology Associates | Pittsburgh | Pennsylvania | 15212 | United States |
| Swedish Medical Center Dept.ofSeattle Neuroscience(2) | Seattle | Washington | 98122-4379 | United States |
| Centre de recherche du CHUM CRCHUM | Montreal | Quebec | H2W 1T8 | Canada |
| CHUL Centre de recherche du CHU | Québec | Quebec | G1V 4G2 | Canada |
| CHUS - Hopital Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Centro Medico Imbanaco de Cali | Cali | Colombia |
| CHU Amiens Picardie Site Nord | Amiens | 80054 | France |
| HCL-Groupe Hospitalier Est | Bron | 69677 | France |
| Recordati Investigative Site | Lille | 59037 | France |
| AP-HM - Hopital de la Conception | Marseille | 13385 | France |
| Hopital Lapeyronie | Montpellier | 34295 | France |
| Hopital Cochin | Paris | 75014 | France |
| Hopital Robert Debre | Reims | 51092 | France |
| HIA Begin | Saint-Mandé | 94160 | France |
| CHU de Saint Etienne | Saint-Priest-en-Jarez | 42277 | France |
| Universitaetsklinikum Aachen | Aachen | 52074 | Germany |
| Universitaetsmedizin Charite | Berlin | 13353 | Germany |
| Univ.-Klinikum Düsseldorf | Düsseldorf | 40225 | Germany |
| Universitaetsklinikum Erlangen Nuernberg | Erlangen | 91054 | Germany |
| Universitaetsklinikum Essen | Essen | 45147 | Germany |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Praxis Dr.med.Frank Ackermann | Halle | 06108 | Germany |
| Universitaetsklinikum Hamburg Eppendorf | Hamburg | 20246 | Germany |
| Universitaetsklinikum Leipzig AoR | Leipzig | 04103 | Germany |
| Universitaetsklinikum Magdeburg AoR | Magdeburg | 39120 | Germany |
| Universitaetsklinikum Muenchen LMU | München | 81377 | Germany |
| Medicover Muenchen Ost MVZ | München | 81667 | Germany |
| Praxis Michael Droste | Oldenburg | 26122 | Germany |
| Universitaetsklinikum Wuerzburg | Würzburg | 97080 | Germany |
| Rabin Medical Centre Belinson | Petah Tikva | 49100 | Israel |
| Tel Aviv Sourasky Medical Centre Ichilov | Tel Aviv | 6423906 | Israel |
| AOU Osp Riuniti Umberto I GM Lancisi G Salesi Univ Studi | Ancona | AN | 60126 | Italy |
| Az.Ospe.Universitaria Policlinico G. Martino Univ.di Messina | Messina | ME | 98125 | Italy |
| Fond IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | MI | 20122 | Italy |
| Stab.Osp.S.Luca P.O. S.Luca-S.Michele-Ist.Auxol. Italiano | Milan | MI | 20149 | Italy |
| Az Osp Univ Policlinico P Giaccone Universita Studi Palermo | Palermo | PA | 90127 | Italy |
| Azienda Ospedaliera di Padova Universita degli Studi | Padova | PD | 35128 | Italy |
| Az Ospedaliero Universitaria Pisana Pres Osped di Cisanello | Pisa | PI | 56124 | Italy |
| P O Molinette AO Citta della Salute e della Scienza Torino | Torino | TO | 10126 | Italy |
| O Universitaria Policlinico Federico II Univ Studi Fed II | Naples | 80131 | Italy |
| Hotel Dieu de France Hospital | El Achrafiyé | 166830 | Lebanon |
| Maastricht Universitair Medisch Centrum | Maastricht | AZ | 5800 | Netherlands |
| Radboudumc | Nijmegen | 6500 HB | Netherlands |
| Spitalul Clinic Judetean de Urgenta Brasov | Brasov | 500365 | Romania |
| Institutul de Endocrinologie "I. C. Parhon", Bucuresti | Bucharest | 011863 | Romania |
| Spitalul Clinic Jude Emergency Clinical County Hospital Cluj | Cluj-Napoca | 400006 | Romania |
| County Hospital Tg. Mures | Târgu Mureş | 540061 | Romania |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies. |
| 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 | No |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c. | Number of pasireotide s.c related adverse events and serious adverse events, when administered as monotherapy or in combination with other therapies in patients with Cushing's disease | Posted | Count of Participants | Participants | 3-year follow-up |
|
|
|
Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.
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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 | All Subjects | Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies. | 5 | 148 | 49 | 148 | 132 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Metabolic alkalosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Cerebrospinal fluid leakage | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral haematoma | Nervous system disorders | Systematic Assessment |
| ||
| Coma | Nervous system disorders | Systematic Assessment |
| ||
| Haemorrhage intracranial | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| IIIrd nerve paresis | Nervous system disorders | Systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Loss of consciousness | Nervous system disorders | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Adrenal insufficiency | Endocrine disorders | Systematic Assessment |
| ||
| Pituitary-dependent Cushing's syndrome | Endocrine disorders | Systematic Assessment |
| ||
| Hyperadrenocorticism | Endocrine disorders | Systematic Assessment |
| ||
| Adrenocortical insufficiency acute | Endocrine disorders | Systematic Assessment |
| ||
| Adrenocorticotropic hormone deficiency | Endocrine disorders | Systematic Assessment |
| ||
| Drug ineffective | General disorders | Systematic Assessment |
| ||
| General physical health deterioration | General disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Meningitis haemophilus | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Pyonephrosis | Infections and infestations | Systematic Assessment |
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| Rhinitis | Infections and infestations | Systematic Assessment |
| ||
| Soft tissue infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | Systematic Assessment |
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| Cortisol increased | Investigations | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | Systematic Assessment |
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| CSF test abnormal | Investigations | Systematic Assessment |
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| Cortisol free urine increased | Investigations | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
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| Grip strength decreased | Investigations | Systematic Assessment |
| ||
| Transaminases increased | Investigations | Systematic Assessment |
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| Weight decreased | Investigations | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal hypermotility | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tooth disorder | Gastrointestinal disorders | Systematic Assessment |
| ||
| Umbilical hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholangitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Pituitary cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Clavicle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post procedural bile leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post procedural complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Stress fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Spondylolisthesis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Calculus urinary | Renal and urinary disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Confusional state | Psychiatric disorders | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Visual impairment | Eye disorders | Systematic Assessment |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperclycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Adrenal Insuffiency | Endocrine disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Drug Ineffective | General disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Hyperadrenocorticism | Endocrine disorders | Systematic Assessment |
| ||
| Hypercholesterolemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Vertigo | Nervous system disorders | Systematic Assessment |
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| Hepatic Steatosis | Hepatobiliary disorders | Systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
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| Feeling cold | General disorders | Systematic Assessment |
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| Hypothyroidism | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
|
Physician or Institution must submit to Sponsor at least 45 days before any publication, the material that they would publish, for Sponsor review and approval of this publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mario Maldonado | Recordati AG | +41798030344 | maldonado.m@recordati.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2023 | Jul 15, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D047748 | Pituitary ACTH Hypersecretion |
| ID | Term |
|---|---|
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C517782 | pasireotide |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|