Real-World Study (RWS) of Lanreotide Autogel (LAN) for the Treatment of Patients With Acromegaly in China
- Conditions
- Acromegaly
- Registration Number
- NCT05431803
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants achieving full biochemical control At 12 months Defined as fasting Growth Hormone (GH) ≤ 2.5 μg/L and Insulin-like Growth Factor-1 (IGF-1) normalization
- Secondary Outcome Measures
Name Time Method 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 vital signs heart rate 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 Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI) From baseline to 12 months Mean change in Clinical laboratory assessments From baseline to 6, and 12 months Including fasting blood glucose, glycated hemoglobin A1C (HbA1c), total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL, and triglycerides
Mean change in fasting GH and IGF-1 concentrations. From baseline to 3, 6, and 12 months Mean change in free thyroxine (FT4) and cortisol for males and females From baseline to 6 and 12 months Mean change in testosterone for males only From baseline to 6 and 12 months Mean change in Quality of Life (QoL) scores From baseline to 6 and 12 months Assessed by the Acromegaly Quality of Life Questionnaire (AcroQoL).
Treatment utilisation of LAN, evaluated by the total number of injections received From baseline to 12 months Mean change in physical examination results From baseline to 3, 6, and 12 months Including Body Mass Index (BMI) and weight
Mean change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol for females only. From baseline to 6 and 12 months Incidence of all Adverse Events (AEs) From baseline to 3, 6 and 12 months Including Serious Adverse Events (SAEs) and special situations assessed according to incidence, intensity, causality, outcome, action taken, and seriousness.
Mean change in vital signs blood pressure From baseline to 3, 6, and 12 months
Trial Locations
- Locations (12)
The First Affiliated Hospital,Sun Yat-sen University (FAHSYSU)
🇨🇳Guangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
🇨🇳Hangzhou, China
The First Hospital of China Medical University (CMU1H)
🇨🇳Shenyang, China
The Second Hospital of Hebei Medical University (HB2H)
🇨🇳Shijiazhuang, China
Peking Union Medical College Hospital (PUMCH)
🇨🇳Beijing, China
Peking University Third Hospital (PUH3)
🇨🇳Beijing, China
Xiangya Hospital Central South University (XYHCSU)
🇨🇳Changsha, China
West China Hospital，Sichuan University (WCH)
🇨🇳Chengdu, China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School (NJDTH)
🇨🇳Nanjing, China
Affiliated Hospital of Wenzhou Medical University (FAHWMU)
🇨🇳Wenzhou, China
The First Affiliated Hospital of Zhengzhou University (FAHZZU)
🇨🇳Zhengzhou, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology (TJH HUST)
🇨🇳Wuhan, China