Cushings DiseaseNCT02310269
Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
An observational study of Cushings Disease, run by RECORDATI GROUP at 54 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushings Disease
- What is being tested?
- Pasireotide
- How many people
- 152 participants
- Where
- 54 sitesin 11 countries
- Study dates
- 28 Mar 2013to 10 Jul 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients with ectopic ACTH-dependent Cushing's syndrome
- Patients with adrenal Cushing's syndrome
- Patients with Pseudo Cushing's syndrome
Trial locations and contacts
54 sites in 11 countries.
54 sites in 11 countries
Germany14 sites
Universitaetsklinikum Aachen
Aachen, 52074
Universitaetsmedizin Charite
Berlin, 13353
Univ.-Klinikum Düsseldorf
Düsseldorf, 40225
Universitaetsklinikum Erlangen Nuernberg
Erlangen, 91054
Universitaetsklinikum Essen
Essen, 45147
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106
Praxis Dr.med.Frank Ackermann
Halle, 06108
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246
Universitaetsklinikum Leipzig AoR
Leipzig, 04103
Universitaetsklinikum Magdeburg AoR
Magdeburg, 39120
Universitaetsklinikum Muenchen LMU
München, 81377
Medicover Muenchen Ost MVZ
München, 81667
Praxis Michael Droste
Oldenburg, 26122
Universitaetsklinikum Wuerzburg
Würzburg, 97080
France9 sites
CHU Amiens Picardie Site Nord
Amiens, 80054
HCL-Groupe Hospitalier Est
Bron, 69677
Recordati Investigative Site
Lille, 59037
AP-HM - Hopital de la Conception
Marseille, 13385
Hopital Lapeyronie
Montpellier, 34295
Hopital Cochin
Paris, 75014
Hopital Robert Debre
Reims, 51092
HIA Begin
Saint-Mandé, 94160
CHU de Saint Etienne
Saint-Priest-en-Jarez, 42277
Italy9 sites
AOU Osp Riuniti Umberto I GM Lancisi G Salesi Univ Studi
Ancona, AN, 60126
Az.Ospe.Universitaria Policlinico G. Martino Univ.di Messina
Messina, ME, 98125
Fond IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, MI, 20122
Stab.Osp.S.Luca P.O. S.Luca-S.Michele-Ist.Auxol. Italiano
Milan, MI, 20149
O Universitaria Policlinico Federico II Univ Studi Fed II
Naples, 80131
Azienda Ospedaliera di Padova Universita degli Studi
Padova, PD, 35128
Az Osp Univ Policlinico P Giaccone Universita Studi Palermo
Palermo, PA, 90127
Az Ospedaliero Universitaria Pisana Pres Osped di Cisanello
Pisa, PI, 56124
P O Molinette AO Citta della Salute e della Scienza Torino
Torino, TO, 10126
United States7 sites
Endocrinology Services
Bend, Oregon, 97702
Massachusetts General Hospital SC - SOM230B2410
Boston, Massachusetts, 02114
Ohio State University SC - SOM230B2410
Columbus, Ohio, 43210
University of Southern California CSOM230B2410 - SC
Los Angeles, California, 90033
St Josephs Hospital and Medical Center
Phoenix, Arizona, 85013
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, 15212
Swedish Medical Center Dept.ofSeattle Neuroscience(2)
Seattle, Washington, 98122-4379
Romania4 sites
Spitalul Clinic Judetean de Urgenta Brasov
Brasov, 500365
Institutul de Endocrinologie "I. C. Parhon", Bucuresti
Bucharest, 011863
Spitalul Clinic Jude Emergency Clinical County Hospital Cluj
Cluj-Napoca, 400006
County Hospital Tg. Mures
Târgu Mureş, 540061
Canada3 sites
Centre de recherche du CHUM CRCHUM
Montreal, Quebec, H2W 1T8
CHUL Centre de recherche du CHU
Québec, Quebec, G1V 4G2
CHUS - Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
Israel2 sites
Rabin Medical Centre Belinson
Petah Tikva, 49100
Tel Aviv Sourasky Medical Centre Ichilov
Tel Aviv, 6423906
Netherlands2 sites
Maastricht Universitair Medisch Centrum
Maastricht, AZ, 5800
Radboudumc
Nijmegen, 6500 HB
United Kingdom2 sites
Derriford Hospital
Plymouth, PL6 8DH
Southampton General Hospital
Southampton, SO16 6YD
About this study
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)
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.
- Conditions
- Cushings Disease
- Being tested
- Pasireotide
- Keywords
- Cushing's disease,, pasireotide s.c., Signifor
- Medical subject headings
- Adrenocortical Hyperfunction, Pituitary ACTH Hypersecretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PasireotideDrug
Also called Signifor
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Pasireotide | |
| Cohort 2/prior use cohort | Subjects who initiated pasireotide s.c. prior to study entry. Receives: Drug: Pasireotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study start28 Mar 2013
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cushings DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- RECORDATI GROUP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario MALDONADO, MD, Study director, Recordati AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310269
- Sponsor's protocol ID
- CSOM230B2410
- Status last verified
- Jul 2024
- First submitted
- 26 Sep 2014
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Manetti L, Deutschbein T, Schopohl J, Yuen KCJ, Roughton M, Kriemler-Krahn U, Tauchmanova L, Maamari R, Giordano C. Long-term safety and efficacy of subcutaneous pasireotide in patients with Cushing's disease: interim results from a long-term real-world evidence study. Pituitary. 2019 Oct;22(5):542-551. doi: 10.1007/s11102-019-00984-6.
PubMed 31440946
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02310269
- Acronym / sponsor ID
- CSOM230B2410
- Conditions
- Cushings Disease
- Keywords
- Cushing's disease,, pasireotide s.c., Signifor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- RECORDATI GROUPIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2013 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1/new use cohort | – | Drug: PasireotideSubjects 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). |
| Cohort 2/prior use cohort | – | Drug: PasireotideSubjects who initiated pasireotide s.c. prior to study entry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with ectopic ACTH-dependent Cushing's syndrome
- Patients with adrenal Cushing's syndrome
- Patients with Pseudo Cushing's syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PasireotideAlso: Signifor | Drug | Cohort 1/new use cohort, Cohort 2/prior use cohort |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31440946Manetti L, Deutschbein T, Schopohl J, Yuen KCJ, Roughton M, Kriemler-Krahn U, Tauchmanova L, Maamari R, Giordano C. Long-term safety and efficacy of subcutaneous pasireotide in patients with Cushing's disease: interim results from a long-term real-world evidence study. Pituitary. 2019 Oct;22(5):542-551. doi: 10.1007/s11102-019-00984-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario MALDONADO, MD study director
Recordati AG
54 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushings Disease, run by RECORDATI GROUP at 54 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Germany, France, Italy, United States, Romania and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c. (time frame: 3-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02310269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.