Brief Title
Real-World Study (RWS) of Lanreotide Autogel (LAN) for the Treatment of Patients With Acromegaly in China
Official Title
Real-World Study of Lanreotide Autogel for the Treatment of Patients With Acromegaly in China
Brief Summary
This study aims to assess the one-year effectiveness and safety of LAN among patients with acromegaly in China in routine clinical practice. In addition, the study is designed to understand the real-world treatment patterns and outcomes of LAN among Chinese patients with acromegaly.
Study Type
Observational
Primary Outcome
Percentage of participants achieving full biochemical control
Secondary Outcome
Percentage of participants achieving fasting GH < 1 μg/L and IGF-1 normalization
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
210
Start Date
June 30, 2022
Completion Date
December 31, 2024
Primary Completion Date
December 31, 2024
Eligibility Criteria
Inclusion Criteria: - Participants who are able to comply with the protocol - Participants with serum IGF-1 level above the ULN for age and sex, and serum fasting GH level above 2.5 μg/L - Participants with acromegaly who are naïve to LAN treatment and about to initiate LAN Exclusion Criteria: - Participants who are currently participating in any investigational study or clinical trial of acromegaly - Pregnant participants - Participants with hypersensitivity to somatostatin or related peptides or to any of the excipients
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical, Director, see email, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT05431803
Organization ID
CLIN-52030-455
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical, Director, Study Director, Ipsen
Verification Date
March 2023