PASPORT Acromegaly, part of the PASPORT clinical trial research program, is a clinical trial to evaluate pasireotide for the treatment of acromegaly.
Key Inclusion Criteria:
At least 18 years of age with active acromegaly
Inadequately controlled acromegaly defined as GH >2.5 µg/L and IGF-1 >1.3 x ULN when receiving maximum indicated doses of octreotide LAR or lanreotide ATG for >6 months given as monotherapy
Patients with micro- or macroadenomas with or without previous surgery
Key Exclusion Criteria:
Patients who have received pasireotide prior to enrollment
Concomitant treatment with GHR-antagonist or dopamine agonists within 8 weeks of randomization
Patients who
Received pituitary irradiation within 10 years
Require surgical intervention for tumor-associated symptom relief
Have compression of the optic chiasm causing clinically significant visual field defects
Known hypersensitivity to somatostatin analogues or any other component of pasireotide LAR
Patients who are hypothyroid and not adequately treated with thyroid hormone replacement therapy
Abbreviations: ATG=autogel; GH=growth hormone; GHR=growth hormone receptor; IGF-1=insulin-like growth factor-1; IM=intramuscular; LAR=long-acting release; SC=subcutaneous; ULN=upper limit of normal
To find out more about this acromegaly clinical trial, Click here.
