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NCT06597383·Not applicable·OBSERVATIONAL

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

PasireotideOtherRecruiting

Status

Recruiting

Phase

Not applicable

Enrollment

100

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed 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.

Interventions

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    Sep 19, 2024

  2. Study start

    Nov 24, 2023

  3. Primary completion

    Nov 2024

  4. Study completion

    Nov 2024

  5. Results posted

    Not reported

  6. Registry updated

    Sep 19, 2024

Outcomes

What the study measures.

Primary outcomes

Evaluate the impact of TTS on disease control in acromegalic patients defined by IGF-1 levels <1.3xULN

Time frame · 12 months

Retrospective data on biochemical and clinical outcomes of patients affected by acromegaly treated with second-line medical therapy will be collected and analyzed. The patients will be stratified based on the therapeutic switch time (Time To Switch, TTS) \< 6 months, between 6 and 12 months and \> 12 months, from 1st generation SSA to the different second-line medical approaches (Pasireotide; Pegvisomant alone; Pegvisomant + first generation SSA combination). The impact of TTS on the biochemical and clinical control of illness will be analyzed.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Italy. Showing up to 24 locations stored in the fast local snapshot.

Andrea Giustina

Milan, Italy

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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