One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With Macroadenoma
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
1 other identifier
observational
54
6 countries
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2012
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2011
CompletedFirst Posted
Study publicly available on registry
November 15, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJanuary 11, 2019
January 1, 2019
1.3 years
November 10, 2011
January 10, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of patients maintained on medical treatment with lanreotide Autogel
1 year
Proportion of patients receiving other medical treatments
1 year
Secondary Outcomes (1)
Proportion of patients with at least one pituitary surgery
1 year
Eligibility Criteria
Outpatients
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (18)
III. Interní klinika Karlova Univerzita
Prague, Czechia
CHU de Rouen
Bois-Guillaume, 76230, France
Groupement hôspitalier est Federation d'endocrinologie.
Bron, France
CHU Michallon
Grenoble, France
Hôpital Claude Huriez
Lille, France
CHU Timone
Marseille, France
Hôpital Bicêtre
Paris, France
Hôpital Haut Leveque
Pessac, France
CHU de Reims
Reims, France
Hôpital Larrey
Toulouse, France
Universität Duisburg-Essen
Essen, Germany
Klinikum der Johann Wolfgang, Goethe-Universität
Frankfurt, Germany
Università Federico II di Napoli
Napoli, Italy
Università Cattolica del Sacro Cuore
Roma, Italy
İstanbul Universitesi, Cerrahpaşa Tıp Fakültesi
Istanbul, Turkey (Türkiye)
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Christie Hospital
Manchester, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2011
First Posted
November 15, 2011
Study Start
January 1, 2012
Primary Completion
May 1, 2013
Study Completion
August 1, 2013
Last Updated
January 11, 2019
Record last verified: 2019-01