An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
ConditionAcromegaly
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCamurus AB
About this trial
The purpose of this study is to collect long-term (up to two years) safety and effectiveness of octreotide subcutaneous depot in patients with acromegaly in the real-world setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have started or will be starting treatment with octreotide SC depot for acromegaly
Disqualifiers
Have started or will be starting treatment with octreotide SC depot for other conditions not related to acromegaly
Currently taking part in an interventional clinical trial or is still within a 30-day washout period from the end of taking part in an interventional clinical trial.
Trial population
The study will enroll patients with acromegaly who are considered for treatment with octreotide subcutaneous depot and patients with acromegaly who have already initiated octreotide subcutaneous depot treatment. The study will be conducted in Germany, the UK, and the US.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Octreotide subcutaneous depot
DrugCommercially available octreotide subcutaneous depot treatment administered by participants for a maximum duration up to 2 years in the study
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Incidence of octreotide SC depot-related AEs and SAEs during 2 years of treatment. Focus is on related AESIs and Other Safety Information.
Time frame
From enrollment to the end of treatment at 2 yearsSecondary outcomes
1
Change in absolute IGF-1 levels and relative IGF-1 (IGF-1/ULN) over time.
Time frame
From enrollment to the end of treatment at 2 years2
Change in proportion of participants with IGF-1 ≤1×ULN over time.
Time frame
From enrollment to the end of treatment at 2 years3
Change in GH levels over time.
Time frame
From enrollment to the end of treatment at 2 years4
Change in proportion of participants with GH levels <1.0 μg/L over time.
Time frame
From enrollment to the end of treatment at 2 years Source ClinicalTrials.gov