One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With Macroadenoma

This non-interventional retrospective study aims to describe the therapeutic procedures and modalities received by patients and the correlation to hormone status, during a one year follow up from completion of the 2-79-52030-207 study.

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

III. Interní klinika Karlova Univerzita, Prague, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Completed the 2-79-52030-207 study and received 12 injections of lanreotide Autogel 120 mg, regardless of efficacy at the end of this period.
Subject or in case of subject's death next of kin having given their written informed consent prior to collection of the data by the sponsor (if locally required)

Treatment and study plan

Primary outcomes

Proportion of patients maintained on medical treatment with lanreotide Autogel

Time frame: 1 year
Proportion of patients receiving other medical treatments

Time frame: 1 year

Secondary outcomes

Proportion of patients with at least one pituitary surgery

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Retrospective Non-interventional Study Evaluating Treatment Adaption During a One Year Follow-up After Completion of the 2-79-52030-207 Study in a Group of Acromegalic Patients With Macroadenoma Who Received 12 Injections of Lanreotide Autogel® 120 mg

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Nov 15, 2011
Registry last updated: Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed