N/A
N=152
Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
Cushings Disease
Bottom Line
View on ClinicalTrials.gov: NCT02310269 ↗Enrolled (actual)
152
Serious AEs
33.1%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c. — 11; 13; 34; 54 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pasireotide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- RECORDATI GROUP
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c. |
11; 13; 34; 54 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02310269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.