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

Launched by IRCCS SAN RAFFAELE · Sep 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how switching patients with acromegaly from first-generation medications to a newer treatment called Pasireotide affects their health. Acromegaly is a condition caused by too much growth hormone, leading to various health issues. The study will examine patients who did not have adequate control of their condition with the first-line treatment and are now being considered for this second-line therapy.

To participate, you must be an adult aged 18 or older, currently diagnosed with acromegaly, and have not achieved good control of your condition with earlier treatments. If you join the study, you will receive the new medication and be monitored for at least 12 months to see how well it works for you. It's important to note that pregnant or breastfeeding women and those under 18 cannot participate. This trial is currently recruiting participants, and your involvement could help researchers understand better ways to treat acromegaly.

Gender

ALL

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