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

Completed

• Conditions: Acromegaly

• Registration Number: NCT01471405
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-15
• Study Start: 2012-01
• Primary Completion: 2013-05
• Study Completion: 2013-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients maintained on medical treatment with lanreotide Autogel	1 year
Proportion of patients receiving other medical treatments	1 year

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with at least one pituitary surgery	1 year

Trial Locations

Locations (18)

CHU Michallon; 🇫🇷 Grenoble, France

Hôpital Haut Leveque; 🇫🇷 Pessac, France

Hôpital Bicêtre; 🇫🇷 Paris, France

CHU de Reims; 🇫🇷 Reims, France

Universität Duisburg-Essen; 🇩🇪 Essen, Germany

CHU de Rouen; 🇫🇷 Bois Guillaume, France

İstanbul Universitesi, Cerrahpaşa Tıp Fakültesi; 🇹🇷 Istanbul, Turkey

Klinikum der Johann Wolfgang, Goethe-Universität; 🇩🇪 Frankfurt, Germany

Hôpital Claude Huriez; 🇫🇷 Lille, France

III. Interní klinika Karlova Univerzita; 🇨🇿 Praha 2, Czechia

Università Cattolica del Sacro Cuore; 🇮🇹 Roma, Italy

Università Federico II di Napoli; 🇮🇹 Napoli, Italy

CHU Timone; 🇫🇷 Marseille, France

Groupement hôspitalier est Federation d'endocrinologie.; 🇫🇷 Bron, France

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, United Kingdom

Hôpital Larrey; 🇫🇷 Toulouse, France

Christie Hospital; 🇬🇧 Manchester, United Kingdom

Derriford Hospital; 🇬🇧 Plymouth, United Kingdom