Clinical trial NCT02310269: Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cushings Disease
Keywords: Cushing's disease,
pasireotide s.c.
Signifor
Lead sponsor: RECORDATI GROUP
Sponsor class: INDUSTRY
First posted: 2014-12-08
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c.
timeFrame: 3-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St Josephs Hospital and Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California CSOM230B2410 - SC
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital SC - SOM230B2410
state: Massachusetts
city: Columbus
country: United States
facility: Ohio State University SC - SOM230B2410
state: Ohio
city: Bend
country: United States
facility: Endocrinology Services
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny Endocrinology Associates
state: Pennsylvania
city: Seattle
country: United States
facility: Swedish Medical Center Dept.ofSeattle Neuroscience(2)
state: Washington
city: Montreal
country: Canada
facility: Centre de recherche du CHUM CRCHUM
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hopital Fleurimont
state: Quebec
city: Quebec
country: Canada
facility: CHUL Centre de recherche du CHU
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali
city: Amiens Cedex 1
country: France
facility: CHU Amiens Picardie Site Nord
city: Bron Cedex
country: France
facility: HCL-Groupe Hospitalier Est
city: Lille Cedex
country: France
facility: Recordati Investigative Site
city: Marseille
country: France
facility: AP-HM - Hopital de la Conception
city: Montpellier Cedex 5
country: France
facility: Hopital Lapeyronie
city: Paris
country: France
facility: Hopital Cochin
city: Reims
country: France
facility: Hopital Robert Debre
city: Saint Mande
country: France
facility: HIA Begin
city: St Priest en Jarez Cedex
country: France
facility: CHU de Saint Etienne
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen
city: Berlin
country: Germany
facility: Universitaetsmedizin Charite
city: Duesseldorf
country: Germany
facility: Univ.-Klinikum Düsseldorf
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen Nuernberg
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Halle
country: Germany
facility: Praxis Dr.med.Frank Ackermann
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig AoR
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg AoR
city: Muenchen
country: Germany
facility: Universitaetsklinikum Muenchen LMU
city: Muenchen
country: Germany
facility: Medicover Muenchen Ost MVZ
city: Oldenburg
country: Germany
facility: Praxis Michael Droste
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Petach Tikva
country: Israel
facility: Rabin Medical Centre Belinson
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Centre Ichilov
city: Ancona
country: Italy
facility: AOU Osp Riuniti Umberto I GM Lancisi G Salesi Univ Studi
state: AN
city: Messina
country: Italy
facility: Az.Ospe.Universitaria Policlinico G. Martino Univ.di Messina
state: ME
city: Milano
country: Italy
facility: Fond IRCCS Ca Granda Ospedale Maggiore Policlinico
state: MI
city: Milano
country: Italy
facility: Stab.Osp.S.Luca P.O. S.Luca-S.Michele-Ist.Auxol. Italiano
state: MI
city: Palermo
country: Italy
facility: Az Osp Univ Policlinico P Giaccone Universita Studi Palermo
state: PA
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova Universita degli Studi
state: PD
city: Pisa
country: Italy
facility: Az Ospedaliero Universitaria Pisana Pres Osped di Cisanello
state: PI
city: Torino
country: Italy
facility: P O Molinette AO Citta della Salute e della Scienza Torino
state: TO
city: Napoli
country: Italy
facility: O Universitaria Policlinico Federico II Univ Studi Fed II
city: El Achrafiyé
country: Lebanon
facility: Hotel Dieu de France Hospital
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
state: AZ
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Brasov
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Brasov
city: Bucuresti
country: Romania
facility: Institutul de Endocrinologie "I. C. Parhon", Bucuresti
city: Cluj
country: Romania
facility: Spitalul Clinic Jude Emergency Clinical County Hospital Cluj
city: Târgu-Mureş
country: Romania
facility: County Hospital Tg. Mures
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Recordati AG
name: Mario MALDONADO, MD
role: STUDY_DIRECTOR
References:
citation: 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.