Pasireotide and Pegvisomant (PAPE) study in Acromegaly

Recruiting

• Conditions: Acromegaly

• Registration Number: NL-OMON26386
• Lead Sponsor: Erasmus University Medical Center Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Written informed consent male or female aged ≥ 18 years

- Documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF-I levels due to a pituitary tumor

Exclusion Criteria

- Has undergone pituitary surgery or radiotherapy within 6 months prior to study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the proportion of patients who achieve normalized IGF-I levels at 24 weeks in each treatment arm.

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of pasireotide LAR (60 mg) alone in normalizing IGF-I levels, within the IGF-I age adjusted normal limits, after 48 weeks of treatment. <br /><br /><br><br>The efficacy of pasireotide LAR (60 mg) combined with PEGV in normalizing IGF-I levels, within the age adjusted normal limits, after 48 weeks of treatment. <br><br /><br /><br>The necessary dose of PEGV, during co-treatment of pasireotide LAR (60 mg) with PEGV in patients with an IGF-I level within the age adjusted normal limits. <br><br /><br /><br>Safety will be assessed based on: adverse events, clinical examination, vital signs, glucose tolerance, EKG, standard hematology, biochemistry, endocrine function tests, GH, PEGV levels and liver function tests.