An observational study in Cushings Disease, sponsored by RECORDATI GROUP. Completed at 54 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by RECORDATI GROUP · Observational
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.
16 studies on the registry are indexed under Adrenocortical Hyperfunction; 1 is open to participants now.
Browse Adrenocortical Hyperfunction studies →RECORDATI GROUP is the lead sponsor of 21 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The patient population will consist of male and 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 and who are treated with pasireotide s.c.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Pasireotide
Subjects who initiated pasireotide s.c. prior to study entry.
Drug: Pasireotide
Also known as: Signifor
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c.
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
Time frame: 3-year follow-up
| Milestone | All Subjects |
|---|---|
| Started | 152 |
| Completed | 29 |
| Not completed | 123 |
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
| Participants | Cohort 1/New Use Cohort | Cohort 2/Prior Use Cohort |
|---|---|---|
| At least 1 treatment-emergent SAE that was suspected to be pasireotide-related. | 11 | 13 |
| A treatment-emergent AE of any grade that was suspected to be pasireotide-related. | 34 | 54 |
Collected over Adverse events and Serious Adverse Events will be followed-up and collected from patient's enrollment into the study until 28 days after the last dose of pasireotide s.c. at the patient's last follow-up visit. Adverse events and Serious Adverse Events will be collected until 3 months after the last dose for patients who permanently discontinue pasireotide s.c. prior to completing 3-year observation period.. Non-serious events are listed at a 2.7% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Subjects | 5/148 (3.4%) | 49/148 (33.1%) | 132/148 (89.2%) |
| Event | All Subjects |
|---|---|
| Cortisol increasedInvestigations | 7/148 |
| HyperglycaemiaMetabolism and nutrition disorders | 6/148 |
| HypoglycaemiaMetabolism and nutrition disorders | 6/148 |
| Drug ineffectiveGeneral disorders | 4/148 |
| CholelithiasisHepatobiliary disorders | 4/148 |
| HypokalaemiaMetabolism and nutrition disorders | 3/148 |
| Type 2 diabetes mellitusMetabolism and nutrition disorders | 3/148 |
| Adrenal insufficiencyEndocrine disorders | 3/148 |
| Pituitary-dependent Cushing's syndromeEndocrine disorders | 3/148 |
| General physical health deteriorationGeneral disorders | 3/148 |
| Event | All Subjects |
|---|---|
| NauseaGastrointestinal disorders | 38/148 |
| DiarrhoeaGastrointestinal disorders | 23/148 |
| Diabetes mellitusMetabolism and nutrition disorders | 19/148 |
| HyperclycaemiaMetabolism and nutrition disorders | 18/148 |
| AstheniaGeneral disorders | 16/148 |
| FatigueGeneral disorders | 16/148 |
| HeadacheNervous system disorders | 16/148 |
| Adrenal InsuffiencyEndocrine disorders | 12/148 |
| Abdominal painGastrointestinal disorders | 11/148 |
| CholelithiasisHepatobiliary disorders | 11/148 |
| Age, Continuous(years) | All Subjects |
|---|---|
| Mean | 49.4 ± 13.64 |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 30 |
| Male | 122 |
| Ethnicity (NIH/OMB)(Participants) | All Subjects |
|---|---|
| Hispanic or Latino | 25 |
| Not Hispanic or Latino | 1 |
| Unknown or Not Reported | 126 |
| Race (NIH/OMB)(Participants) | All Subjects |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 118 |
| More than one race | 0 |
| Unknown or Not Reported | 33 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Adrenocortical Hyperfunction →