Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Camurus AB
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients, ≥18 years at screening
Able to provide written informed consent to participate in the trial
Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly
Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening
IGF-1 levels ˃1xULN and ≤2.0xULN at screening or IGF-1 levels ≤1xULN at screening with or without prior pituitary radiotherapy
Adequate liver, pancreatic, renal and bone marrow functions
Normal ECG
You may not be if
For Roll-over Patients from NCT04076462:
Unresolved, drug-related serious adverse event (SAE) from the preceding trial
Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation
For New Patients:
Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening \[whichever is longer\]
Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated
Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening
Patients who have undergone pituitary surgery within 6 months prior to screening
Patients who have received prior pituitary irradiation within 3 years prior to screening
Patients with poorly controlled diabetes mellitus (hemoglobin A1c \>8.0%)
Clareo Health | A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
