Real-World Study (RWS) of Lanreotide Autogel (LAN) for the Treatment of Patients With Acromegaly in China
Real-World Study of Lanreotide Autogel for the Treatment of Patients With Acromegaly in China
1 other identifier
observational
129
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2022
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedStudy Start
First participant enrolled
June 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2024
CompletedJanuary 31, 2025
January 1, 2025
2.5 years
June 20, 2022
January 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants achieving full biochemical control
Defined as fasting Growth Hormone (GH) ≤ 2.5 μg/L and Insulin-like Growth Factor-1 (IGF-1) normalization
At 12 months
Secondary Outcomes (15)
Percentage of participants achieving fasting GH < 1 μg/L and IGF-1 normalization
At 12 months
Percentage of participants achieving fasting GH ≤2.5 μg/L and IGF-1 ≤1.3 Upper Limit of Normal (ULN)
At 12 months
Mean change in fasting GH and IGF-1 concentrations.
From baseline to 3, 6, and 12 months
Mean change in the proportion of patients experiencing each of the symptoms (headache, excessive sweating, joint pain, fatigue, and soft tissue swelling) as evaluated by physicians.
From baseline to 6 and 12 months
Mean change in Quality of Life (QoL) scores
From baseline to 6 and 12 months
- +10 more secondary outcomes
Eligibility Criteria
Adult participants who have been diagnosed with acromegaly and initiating LAN treatment
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (12)
Peking Union Medical College Hospital (PUMCH)
Beijing, 100000, China
Peking University Third Hospital (PUH3)
Beijing, 100000, China
Xiangya Hospital Central South University (XYHCSU)
Changsha, 410000, China
West China Hospital，Sichuan University (WCH)
Chengdu, 610000, China
The First Affiliated Hospital,Sun Yat-sen University (FAHSYSU)
Guangzhou, 510000, China
The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
Hangzhou, 310000, China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School (NJDTH)
Nanjing, 210000, China
The First Hospital of China Medical University (CMU1H)
Shenyang, 110000, China
The Second Hospital of Hebei Medical University (HB2H)
Shijiazhuang, 050000, China
Affiliated Hospital of Wenzhou Medical University (FAHWMU)
Wenzhou, 325000, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology (TJH HUST)
Wuhan, 430000, China
The First Affiliated Hospital of Zhengzhou University (FAHZZU)
Zhengzhou, 450000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical, Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2022
First Posted
June 24, 2022
Study Start
June 30, 2022
Primary Completion
December 13, 2024
Study Completion
December 13, 2024
Last Updated
January 31, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.