Brief Title
Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly
Official Title
Non-interventional, Prospective Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly
Brief Summary
The purpose of the study is to collect data about predictive factors for the efficacy of Lanreotide Autogel in patients with acromegaly in routine clinical practice.
Study Type
Observational
Primary Outcome
Proportion of subjects with normalization of centrally assessed age and sex adjusted IGF-I levels at visit 4 (about 12 months) after treatment start with lanreotide autogel.
Secondary Outcome
Proportion of subjects with normalization of centrally assessed age- and sex-adjusted IGF-I levels at visit 2, 3, and 5 after treatment start with lanreotide autogel
Condition
Acromegaly
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
0
Start Date
April 2020
Completion Date
December 30, 2023
Primary Completion Date
June 30, 2023
Eligibility Criteria
Inclusion Criteria: - Male or female aged 18 years and older with the capacity to consent - Signed written informed consent - Subject with hormonally active acromegaly defined by locally measured IGF-I levels 1.3 times above the age- and sex-adjusted normal range as determined at the last routine visit before baseline and after surgery - Subject with the intention to be treated with lanreotide autogel according to the current local SmPC (Germany, Austria) prior to study enrolment Exclusion Criteria: - Participation in an interventional trial at the same time and/or within 3 months before baseline - Subject represented by a legal guardian
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Administrative Informations
NCT ID
NCT04003519
Organization ID
A-DE-52030-368
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
June 2020