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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT02310269
• Date of registration: 26/09/2014
• Prospective Registration: No
• Primary sponsor: RECORDATI GROUP
• Public title: Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
• Scientific 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)
• Date of first enrolment: March 28, 2013
• Target sample size: 151
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02310269
• Study type: Observational

Countries of recruitment

Canada, Colombia, Denmark, France, Germany, Israel, Italy, Lebanon, Netherlands, Romania, Sweden, United Kingdom, United States

Contacts

• Name: Recordati
• Affiliation: Recordati Rare Diseases

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cushings Disease

Intervention(s)

Drug: SOM230

Primary Outcome(s)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability profile of pasireotide s.c. [Time Frame: 3-year follow-up]

Secondary Outcome(s)

Changes of ACTH measures of disease activtity [Time Frame: 3-year follow-up]

Changes of mean UFC measures of disease activity [Time Frame: 3-year follow-up]

Change of serum cortisol measures of disease activity [Time Frame: 3-year follow-up]

Proportion of patients achieving serum cortisol after dexamethasone testing Normalization of disease activity [Time Frame: 3-year follow-up]

Proportion of patients achieving serum cortisol Normalization of disease activity [Time Frame: 3-year follow-up]

The proportion of patients that reach mean UFC = ULN as short and long-term efficacy measure [Time Frame: At 1, 3, 6, 12, 24 and 36 months after enrolling into the study]

Changes in safety and efficacy parameters over a period of 3 months [Time Frame: 3 months after patient's discontinuation]

The absolute and percentage change of body weight from baseline [Time Frame: 3-year follow-up]

The absolute and percentage change of waist circumference from baseline [Time Frame: 3-year follow-up]

Proportion of patients achieving salivary cortisol Normalization of disease activity [Time Frame: 3-year follow-up]

The absolute and percentage change of body mass index from baseline [Time Frame: 3-year follow-up]

The proportion of patients with favorable shift of blood pressure from baseline [Time Frame: 3-year follow-up]

The proportion of patients with favorable shift of waist circumference from baseline [Time Frame: 3-year follow-up]

The proportion of patients with favorable shift of body mass index from baseline [Time Frame: 3-year follow-up]

The proportion of patients with favorable shift of body weight from baseline [Time Frame: 3-year follow-up]

Changes of fasting serum lipid profile measures of disease activtity [Time Frame: 3-year follow-up]

Changes of salivary cortisol measures of disease activity [Time Frame: 3-year follow-up]

Proportion of patients achieving ACTH Normalization of disease activity [Time Frame: 3-year follow-up]

The absolute and percentage change in tumor size [Time Frame: 3-year follow-up]

Change of serum cortisol after dexamathasone testing measures of disease activity [Time Frame: 3-year followup]

The absolute and percentage change from baseline in patient-reported outcome questionnaires [Time Frame: 3-year follow-up]

The absolute and percentage change of blood pressure from baseline [Time Frame: 3-year follow-up]

Secondary ID(s)

CSOM230B2410

Source(s) of Monetary Support

Please refer to primary and secondary sponsors