Status:
RECRUITING
The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly
Lead Sponsor:
IRCCS San Raffaele
Collaborating Sponsors:
University of Turin, Italy
University of Padova
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
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 pati...
Eligibility Criteria
Inclusion
- Adult men and women (age ≥ 18 years) affected by acromegaly, including those of childbearing age
- Patients inadequately controlled with first generation somatostatin analogues (GH ≥1 μg/L and IGF-1 \>1.3×ULN)
- Second line medical treatment (Pasireotide; Pegvisomant only; combination Pegvisomant + 1st generation SSA) after use of first-line medical treatment
- At least 12 months of follow up during 2nd line therapy
- Signature of the informed consent to the study
Exclusion
- age ≤18 years
- Pregnant and/or breastfeeding women
- Patients unable to understand and sign the Informed Consent
Key Trial Info
Start Date :
November 24 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06597383
Start Date
November 24 2023
End Date
November 1 2024
Last Update
September 19 2024
Active Locations (1)
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1
Andrea Giustina
Milan, Italy, 20132