Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study)
1 other identifier
observational
152
11 countries
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2013
Longer than P75 for all trials
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2013
CompletedFirst Submitted
Initial submission to the registry
September 26, 2014
CompletedFirst Posted
Study publicly available on registry
December 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2023
CompletedResults Posted
Study results publicly available
October 15, 2024
CompletedOctober 15, 2024
July 1, 2024
10.3 years
September 26, 2014
July 19, 2024
July 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patients with ectopic ACTH-dependent Cushing's syndrome
- Patients with adrenal Cushing's syndrome
- Patients with Pseudo Cushing's syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RECORDATI GROUPlead
Study Sites (54)
St Josephs Hospital and Medical Center
Phoenix, Arizona, 85013, United States
University of Southern California CSOM230B2410 - SC
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
Padua, 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
Napoli, 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
Related Publications (1)
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.
PMID: 31440946DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mario Maldonado
- Organization
- Recordati AG
Study Officials
- STUDY DIRECTOR
Mario MALDONADO, MD
Recordati AG
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2014
First Posted
December 8, 2014
Study Start
March 28, 2013
Primary Completion
July 10, 2023
Study Completion
July 10, 2023
Last Updated
October 15, 2024
Results First Posted
October 15, 2024
Record last verified: 2024-07