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

Last updated: September 11, 2024
Sponsor: IRCCS San Raffaele
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acromegaly

Treatment

N/A

Clinical Study ID

NCT06597383
RAPSODIA
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Adult men and women (age ≥ 18 years) affected by acromegaly, including those ofchildbearing 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; combinationPegvisomant + 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

Exclusion Criteria:

  • age ≤18 years

  • Pregnant and/or breastfeeding women

  • Patients unable to understand and sign the Informed Consent

Study Design

Total Participants: 100
Study Start date:
November 24, 2023
Estimated Completion Date:
November 30, 2024

Study 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 patients which neurosurgical intervention was not completely effective or contraindicated or rejected by the patient and for which first-line medical therapy with first-generation somatostatin analogues (octreotide LAR or lanreotide) did not result in disease control and switched to second-line medical therapy will be enrolled. The TTS is the time defined in days and months from the observation that disease is no longer biochemically controlled, defined by the presence of GH levels ≥1 μg/L and IGF-1>1.3×ULN (upper limit of normal), during 1st line therapy, and the start of 2nd line therapy line.

Connect with a study center

  • Andrea Giustina

    Milan, 20132
    Italy

    Active - Recruiting

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