Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT02310269Other idCSOM230B2410

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase not stated
Enrollment: 152 participants (actual)
Sponsor: RECORDATI GROUP · Industry
Design: Not stated
Countries: 11 countries
United States, Canada, Colombia, France, Germany, Israel, Italy, Lebanon, Netherlands, Romania, United Kingdom
Start: 28 Mar 2013
Primary completion: 10 Jul 2023
Completion: 10 Jul 2023
First posted: 8 Dec 2014 (estimated)
Last update posted: 15 Oct 2024
Conditions: Cushings Disease

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201420162018202020222024

Ph –
Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
NCT02310269
28 Mar 2013 to 10 Jul 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

PasireotideDrug

Arms2

Other
Cohort 1/new use cohort
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).
Other
Cohort 2/prior use cohort
Subjects who initiated pasireotide s.c. prior to study entry.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c.
Time frame · 3-year follow-up
Registry description
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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 3-year follow-up

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

Group	Value (Participants)
Cohort 1/New Use Cohort	11
Cohort 2/Prior Use Cohort	13

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
All SubjectsPatients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies.	5 / 148	49 / 148	132 / 148

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2019

Long-term safety and efficacy of subcutaneous pasireotide in patients with Cushing's disease: interim results from a long-term real-world evidence study.

Manetti et al. 2019Pituitarycited by 14

PMID 31440946PMC6728293DOI 10.1007/s11102-019-00984-6PUB-31440946

CC BY

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Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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