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Recruiting NCT06597383

The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly

Trial Parameters

Condition Acromegaly
Sponsor IRCCS San Raffaele
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-11-24
Completion 2024-11

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.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * age ≤18 years * Pregnant and/or breastfeeding women * Patients unable to understand and sign the Informed Consent

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