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

Recordati

Status: Completed

Conditions: Cushings Disease

Treatments: Drug: Pasireotide

Study type: Observational

Funder types: Industry

Identifiers

NCT02310269

CSOM230B2410

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

152 participants in 2 patient groups

Cohort 1/new use cohort

Description:

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).

Treatment:

Drug: Pasireotide

Cohort 2/prior use cohort

Description:

Subjects who initiated pasireotide s.c. prior to study entry.

Treatment:

Drug: Pasireotide