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

Completed

• Conditions: Cushings Disease
• Interventions: Drug: Pasireotide

• Registration Number: NCT02310269
• Lead Sponsor: RECORDATI GROUP

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-28
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-08
• Primary Completion: 2023-07-10
• Study Completion: 2023-07-10
• Status Verified: 2024-07
• Results First Submitted: 2024-07-19
• Results First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Results First Posted: 2024-10-14
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1/new use cohort	Pasireotide	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).
Cohort 2/prior use cohort	Pasireotide	Subjects who initiated pasireotide s.c. prior to study entry.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c.	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

Trial Locations

Locations (54)

Centre de recherche du CHUM CRCHUM; 🇨🇦 Montreal, Quebec, Canada

CHUS - Hopital Fleurimont; 🇨🇦 Sherbrooke, Quebec, Canada

CHUL Centre de recherche du CHU; 🇨🇦 Quebec, Canada

Centro Medico Imbanaco de Cali; 🇨🇴 Cali, Colombia

CHU Amiens Picardie Site Nord; 🇫🇷 Amiens Cedex 1, France

HCL-Groupe Hospitalier Est; 🇫🇷 Bron Cedex, France

AP-HM - Hopital de la Conception; 🇫🇷 Marseille, France

Hopital Lapeyronie; 🇫🇷 Montpellier Cedex 5, France

Hopital Cochin; 🇫🇷 Paris, France

Hopital Robert Debre; 🇫🇷 Reims, France

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