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

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.

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Key information

Conditions

Cushings Disease Adrenal Gland Diseases Adrenocortical Hyperfunction Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Nervous System Diseases Pituitary ACTH Hypersecretion Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de recherche du CHUM CRCHUM, Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pasireotide

Drug

Other names: Signifor

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

Sponsors and collaborators

Lead sponsor

RECORDATI GROUP

Industry

Registry information

Official study 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)

Important dates

Study start: 2013
Primary completion: 2023
Study completion: 2023
First posted: Dec 8, 2014
Registry last updated: Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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