Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
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| ClinicalTrials.gov Identifier: NCT02310269 |
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Recruitment Status :
Recruiting
First Posted : December 8, 2014
Last Update Posted : May 20, 2022
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Sponsor:
RECORDATI GROUP
Information provided by (Responsible Party):
RECORDATI GROUP
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Cushings Disease | Drug: SOM230 |
| Study Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official 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) |
| Actual Study Start Date : | March 28, 2013 |
| Estimated Primary Completion Date : | September 27, 2023 |
| Estimated Study Completion Date : | May 1, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cushing disease
MedlinePlus related topics:
Safety
Drug Information available for:
Pasireotide
| Group/Cohort | Intervention/treatment |
|---|---|
| Pasireotide |
Drug: SOM230 |
Primary Outcome Measures :
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability profile of pasireotide s.c. [ Time Frame: 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
Secondary Outcome Measures :
- 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 ]The proportion of patients with a mean UFC ≤ ULN at 1, 3, 6, 12, 24 and 36 months after enrolling into the study
- Changes of mean UFC measures of disease activity [ Time Frame: 3-year follow-up ]The absolute and percentage change from baseline of mean UFC measures of disease activity after enrolling into the study.
- Proportion of patients achieving serum cortisol Normalization of disease activity [ Time Frame: 3-year follow-up ]Proportion of patients achieving serum cortisol Normalization of disease activity where normalization refers to being within the upper and lower limit of normal ranges
- The absolute and percentage change of blood pressure from baseline [ Time Frame: 3-year follow-up ]The absolute and percentage change of blood pressure from baseline after enrolling into the study
- 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 blood pressure from baseline 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 ]Safety parameters include: Adverse events , Serious Adverse Events, vital signs, blood pressure, heart rate, body temperature, blood glucose (fasting plasma glucose, HemoglobinA1c), hormones (IGF-1, GH, TSH/free T4), liver enzymes (AST, ALT, alkaline phosphatase, γGT, total bilirubin), hematology, electrolytes, immunological events (e.g., allergic reactions: rash, pruritus, injection site reactions), gallbladder ultrasound and ECGs. Efficacy parameters include: Urinary Free Cortisol, serum cortisol, serum cortisol after dexamethasone testing, salivary cortisol, plasma ACTH, fasting serum lipid profile, Blood pressure, body weight, body mass index, waist circumference, tumor size and quality of life.
- The absolute and percentage change in tumor size [ Time Frame: 3-year follow-up ]The absolute and percentage change in tumor size after enrolling into the study
- The absolute and percentage change from baseline in patient-reported outcome questionnaires [ Time Frame: 3-year follow-up ]The absolute and percentage change from baseline in patient -reported outcome questionnaires (Cushing QoL and EURO QoL) after enrolling into the study
- Change of serum cortisol measures of disease activity [ Time Frame: 3-year follow-up ]The absolute and percentage change from baseline of serum cortisol measures of disease activity after enrolling into the study
- Change of serum cortisol after dexamathasone testing measures of disease activity [ Time Frame: 3-year followup ]The absolute and percentage change from baseline of serum cortisol after dexamathasone testing measures of disease activity after enrolling into the study
- Changes of salivary cortisol measures of disease activity [ Time Frame: 3-year follow-up ]The absolute and percentage change from baseline of salivary cortisol measures of disease activity after enrolling into the study
- Changes of ACTH measures of disease activtity [ Time Frame: 3-year follow-up ]The absolute and percentage change from baseline of ACTH measures of disease activity after enrolling into the study
- 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 after dexamethasone testing Normalization of disease activity where normalization refers to being within the upper and lower limit of normal ranges
- Proportion of patients achieving salivary cortisol Normalization of disease activity [ Time Frame: 3-year follow-up ]Proportion of patients achieving salivary cortisol of disease activity where normalization refers to being within the upper and lower limit of normal ranges
- Proportion of patients achieving ACTH Normalization of disease activity [ Time Frame: 3-year follow-up ]Proportion of patients achieving ACTH of disease activity where normalization refers to being within the upper and lower limit of normal ranges
- Changes of fasting serum lipid profile measures of disease activtity [ Time Frame: 3-year follow-up ]The absolute and percentage change from baseline of fasting serum lipid profile measures of disease activity after enrolling into the study
- The absolute and percentage change of body weight from baseline [ Time Frame: 3-year follow-up ]The absolute and percentage change of body weight from baseline after enrolling into the study
- The absolute and percentage change of body mass index from baseline [ Time Frame: 3-year follow-up ]The absolute and percentage change of body mass index from baseline after enrolling into the study
- The absolute and percentage change of waist circumference from baseline [ Time Frame: 3-year follow-up ]The absolute and percentage change of waist circumference from baseline after enrolling into the study
- The proportion of patients with favorable shift of body weight from baseline [ Time Frame: 3-year follow-up ]The proportion of patients with favorable shift of body weight from baseline after enrolling into the study
- 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 mass index from baseline after enrolling into the study
- 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 waist circumference from baseline after enrolling into the study
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310269
Contacts
| Contact: Recordati | +390248787122 | ||
| Contact: Recordati | +41612056100 |
Locations
Show 71 study locations
Sponsors and Collaborators
RECORDATI GROUP
Investigators
| Study Director: | Recordati | Recordati Rare Diseases |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | RECORDATI GROUP |
| ClinicalTrials.gov Identifier: | NCT02310269 |
| Other Study ID Numbers: |
CSOM230B2410 |
| First Posted: | December 8, 2014 Key Record Dates |
| Last Update Posted: | May 20, 2022 |
| Last Verified: | May 2022 |
Keywords provided by RECORDATI GROUP:
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Cushing's disease, pasireotide s.c. Signifor |
Additional relevant MeSH terms:
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ACTH-Secreting Pituitary Adenoma Pituitary ACTH Hypersecretion Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Adenoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pituitary Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Pasireotide Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |