Pasireotide LAR and Pegvisomant Study in Acromegaly

What Was Tested

The trial (phase 4) is built around Pasireotide.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: has undergone pituitary surgery or radiotherapy within 6 months prior to study entry; it is anticipated that the patient will receive pituitary surgery or radiotherapy during the study; has a history of hypersensitivity to lanreotide, octreotide or pegvisomant or drugs with a similar chemical structure.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Pasireotide study: the participants and staff both knew the treatment.

It started in 2015-08 with completion listed for 2017-03.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The proportion of patients with normalized IGF1 levels at 24 weeks in the pasireotide LAR monotherapy group and in the pasireotide LAR combined with pegvisomant group (time frame: 24 weeks).

It also tracked 10 secondary outcomes, for example The proportion of patients with normalized IGF1 levels after 48 weeks of pasireotide LAR monotherapy, The proportion of patients with normalized IGF1 levels after 48 weeks combination treatment of pasireotide LAR with weekly pegvisomant, Change in tumor volume by pituitary MRI, Tolerability and safety profile of pasireotide Long Acting Release (LAR) monotherapy, Tolerability and safety profile of pasireotide LAR and pegvisomant combination therapy and Evaluation of long term effect of pasireotide LAR with or without pegvisomant on AcroQol, PASQ and signs and symptoms of acromegaly.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Pasireotide in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Pasireotide compound page, all human trials.