RecruitingNCT06597383

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

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

Sponsor

IRCCS San Raffaele

Enrollment

100 participants

Start Date

Nov 24, 2023

Study Type

OBSERVATIONAL

Conditions

Acromegaly

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria3

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

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Locations(1)

Andrea Giustina

Milan, Italy

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NCT06597383

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