Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease

Completed

Conditions studied: Cushings Disease

In brief

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.

Key facts

Study ID

NCT02310269

Run by

RECORDATI GROUP

People needed

152

Starts

2013-03-28

Expected to finish

2023-07-10

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Universitaetsklinikum Essen — Essen, Germany
• St Josephs Hospital and Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.