Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
- Registration Number
- NCT02310269
- Lead Sponsor
- RECORDATI GROUP
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
- Written informed consent or equivalent document (e.g., written information) as per country regulation prior to registration of any patient data
- Male or 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
- Patients must be treated with pasireotide s.c. started either at the first visit for this study or prior to study entry
- Patients with ectopic ACTH-dependent Cushing's syndrome
- Patients with adrenal Cushing's syndrome
- Patients with Pseudo Cushing's syndrome
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1/new use cohort Pasireotide 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 Pasireotide Subjects who initiated pasireotide s.c. prior to study entry.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c. 3-year follow-up 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (54)
Centre de recherche du CHUM CRCHUM
🇨🇦Montreal, Quebec, Canada
CHUS - Hopital Fleurimont
🇨🇦Sherbrooke, Quebec, Canada
CHUL Centre de recherche du CHU
🇨🇦Quebec, Canada
Centro Medico Imbanaco de Cali
🇨🇴Cali, Colombia
CHU Amiens Picardie Site Nord
🇫🇷Amiens Cedex 1, France
HCL-Groupe Hospitalier Est
🇫🇷Bron Cedex, France
AP-HM - Hopital de la Conception
🇫🇷Marseille, France
Hopital Lapeyronie
🇫🇷Montpellier Cedex 5, France
Hopital Cochin
🇫🇷Paris, France
Hopital Robert Debre
🇫🇷Reims, France
HIA Begin
🇫🇷Saint Mande, France
CHU de Saint Etienne
🇫🇷St Priest en Jarez Cedex, France
Universitaetsklinikum Aachen
🇩🇪Aachen, Germany
Universitaetsmedizin Charite
🇩🇪Berlin, Germany
Univ.-Klinikum Düsseldorf
🇩🇪Duesseldorf, Germany
Universitaetsklinikum Erlangen Nuernberg
🇩🇪Erlangen, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
Praxis Dr.med.Frank Ackermann
🇩🇪Halle, Germany
Universitaetsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Universitaetsklinikum Leipzig AoR
🇩🇪Leipzig, Germany
Universitaetsklinikum Magdeburg AoR
🇩🇪Magdeburg, Germany
Universitaetsklinikum Muenchen LMU
🇩🇪Muenchen, Germany
Medicover Muenchen Ost MVZ
🇩🇪Muenchen, Germany
Praxis Michael Droste
🇩🇪Oldenburg, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
Rabin Medical Centre Belinson
🇮🇱Petach Tikva, Israel
Tel Aviv Sourasky Medical Centre Ichilov
🇮🇱Tel Aviv, Israel
AOU Osp Riuniti Umberto I GM Lancisi G Salesi Univ Studi
🇮🇹Ancona, AN, Italy
Az.Ospe.Universitaria Policlinico G. Martino Univ.di Messina
🇮🇹Messina, ME, Italy
Fond IRCCS Ca Granda Ospedale Maggiore Policlinico
🇮🇹Milano, MI, Italy
Stab.Osp.S.Luca P.O. S.Luca-S.Michele-Ist.Auxol. Italiano
🇮🇹Milano, MI, Italy
Az Osp Univ Policlinico P Giaccone Universita Studi Palermo
🇮🇹Palermo, PA, Italy
Azienda Ospedaliera di Padova Universita degli Studi
🇮🇹Padova, PD, Italy
Az Ospedaliero Universitaria Pisana Pres Osped di Cisanello
🇮🇹Pisa, PI, Italy
P O Molinette AO Citta della Salute e della Scienza Torino
🇮🇹Torino, TO, Italy
O Universitaria Policlinico Federico II Univ Studi Fed II
🇮🇹Napoli, Italy
Hotel Dieu de France Hospital
🇱🇧El Achrafiyé, Lebanon
Maastricht Universitair Medisch Centrum
🇳🇱Maastricht, AZ, Netherlands
Radboudumc
🇳🇱Nijmegen, Netherlands
Spitalul Clinic Judetean de Urgenta Brasov
🇷🇴Brasov, Romania
Institutul de Endocrinologie "I. C. Parhon", Bucuresti
🇷🇴Bucuresti, Romania
Spitalul Clinic Jude Emergency Clinical County Hospital Cluj
🇷🇴Cluj, Romania
County Hospital Tg. Mures
🇷🇴Târgu-Mureş, Romania
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
St Josephs Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
University of Southern California CSOM230B2410 - SC
🇺🇸Los Angeles, California, United States
Massachusetts General Hospital SC - SOM230B2410
🇺🇸Boston, Massachusetts, United States
Ohio State University SC - SOM230B2410
🇺🇸Columbus, Ohio, United States
Endocrinology Services
🇺🇸Bend, Oregon, United States
Allegheny Endocrinology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Swedish Medical Center Dept.ofSeattle Neuroscience(2)
🇺🇸Seattle, Washington, United States
Recordati Investigative Site
🇫🇷Lille Cedex, France