Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597383
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly RAPSODIA
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPSODIA
Brief Summary:
This is an observational retrospective national multicenter study aimed to evaluate the impact and efficacy of Time To Switch TTS from first-line to second-line medical therapy in Acromegaly
Detailed Description:
The study will retrospectively collect clinical laboratory and anamnestic data of approximately 100 patients evaluated at the UOs involved in the study in last 5 years and 6 months
Acromegalic patients which neurosurgical intervention was not completely effective or contraindicated or rejected by the patient and for which first-line medical therapy with first-generation somatostatin analogues octreotide LAR or lanreotide did not result in disease control and switched to second-line medical therapy will be enrolled The TTS is the time defined in days and months from the observation that disease is no longer biochemically controlled defined by the presence of GH levels 1 μgL and IGF-113ULN upper limit of normal during 1st line therapy and the start of 2nd line therapy line
Acromegalic patients which neurosurgical intervention was not completely effective or contraindicated or rejected by the patient and for which first-line medical therapy with first-generation somatostatin analogues octreotide LAR or lanreotide did not result in disease control and switched to second-line medical therapy will be enrolled The TTS is the time defined in days and months from the observation that disease is no longer biochemically controlled defined by the presence of GH levels 1 μgL and IGF-113ULN upper limit of normal during 1st line therapy and the start of 2nd line therapy line
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None