NCT06597383 The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly
| NCT ID | NCT06597383 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Acromegaly |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-11-24 |
| Primary Completion | 2024-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-11-24 with a primary completion date of 2024-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06597383 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acromegaly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06597383 currently recruiting?
Yes, NCT06597383 is actively recruiting participants. Contact the research team at difilippo.luigi@hsr.it for enrollment information.
Where is the NCT06597383 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06597383 clinical trial?
NCT06597383 is sponsored by IRCCS San Raffaele. The trial plans to enroll 100 participants.