Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies

What Was Tested

In this phase 4 trial, researchers set out to test Pasireotide.

It had two arms (groups): Pasireotide subcutaneous (experimental) and Pasireotide Long Acting Release (LAR) (experimental).

The registry classes the interventions as drug.

More on the Plan

Eligible patients are to be consented and can then continue treatment with pasireotide alone or in combination with another treatment for Cushing's Disease and Acromegaly in this protocol.

All patients at their scheduled visits will have drug dispensing information and reported adverse events and serious adverse events collected.

A patient will reach the end of study when pasireotide treatment is permanently discontinued and the end of treatment visit has been performed.

The study is expected to remain open for approximately 10 years or until such time that enrolled patients no longer need treatment with pasireotide or are able to obtain commercial supply according to local regulations for their medical condition.

Who Took Part

337 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: Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. Written informed consent obtained prior to enrolling in roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

The full record lists 6 inclusion and 10 exclusion criteria.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The Pasireotide group and the comparison group ran side by side rather than switching.

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

It started in 2013-06-10 with completion listed for 2023-07-25.

It ran at 94 sites in Belgium (8), France (8), United States (7), Brazil (7), Germany (7) and Japan (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence of Adverse Events to Evaluate Long Term Safety Data (time frame: Baseline up to approximately 10 years).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Pasireotide in 337 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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