DRUG
Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
Status
Completed
Phase
Not applicable
Enrollment
152
Locations
54
Results
Posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Dec 8, 2014
Study start
Mar 28, 2013
Primary completion
Jul 10, 2023
Study completion
Jul 10, 2023
Results posted
Oct 15, 2024
Registry updated
Oct 15, 2024
Outcomes
What the study measures.
Primary outcomes
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c.
Time frame · 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 outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with ectopic ACTH-dependent Cushing's syndrome * Patients with adrenal Cushing's syndrome * Patients with Pseudo Cushing's syndrome
Study locations
54 registered sites.
Canada · Colombia · France · Germany · Israel · Italy · Lebanon · Netherlands · Romania · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Centre de recherche du CHUM CRCHUM
Montreal, Quebec, Canada
CHUL Centre de recherche du CHU
Québec, Quebec, Canada
CHUS - Hopital Fleurimont
Sherbrooke, Quebec, Canada
Centro Medico Imbanaco de Cali
Cali, Colombia
CHU Amiens Picardie Site Nord
Amiens, France
HCL-Groupe Hospitalier Est
Bron, France
Recordati Investigative Site
Lille, France
AP-HM - Hopital de la Conception
Marseille, France
Hopital Lapeyronie
Montpellier, France
Hopital Cochin
Paris, France
Hopital Robert Debre
Reims, France
HIA Begin
Saint-Mandé, France
CHU de Saint Etienne
Saint-Priest-en-Jarez, France
Universitaetsklinikum Aachen
Aachen, Germany
Universitaetsmedizin Charite
Berlin, Germany
Univ.-Klinikum Düsseldorf
Düsseldorf, Germany
Universitaetsklinikum Erlangen Nuernberg
Erlangen, Germany
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