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

RECORDATI GROUP152 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

152

Conditions

Cushings Disease

Interventions

PasireotideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (54)

Outcomes

Primary Outcomes

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

Time frame: 3-year follow-up

Data from ClinicalTrials.gov

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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

...and 44 more locations