Real-World Study (RWS) of Lanreotide Autogel (LAN) for the Treatment of Patients With Acromegaly in China

Acromegaly Clinical Trial

Official title:

Real-World Study of Lanreotide Autogel for the Treatment of Patients With Acromegaly in China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05431803
• Other study ID #: CLIN-52030-455
• Status: Active, not recruiting
• Start date: June 30, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Locations

Country	Name	City	State
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	The First Affiliated Hospital,Sun Yat-sen University (FAHSYSU)	Guangzhou
China	The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)	Hangzhou
China	Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School (NJDTH)	Nanjing
China	The First Hospital of China Medical University (CMU1H)	Shenyang
China	The Second Hospital of Hebei Medical University (HB2H)	Shijiazhuang
China	Affiliated Hospital of Wenzhou Medical University (FAHWMU)	Wenzhou
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology (TJH HUST)	Wuhan
China	The First Affiliated Hospital of Zhengzhou University (FAHZZU)	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of participants achieving fasting GH < 1 µg/L and IGF-1 normalization		At 12 months
Secondary	Percentage of participants achieving fasting GH =2.5 µg/L and IGF-1 =1.3 Upper Limit of Normal (ULN)		At 12 months
Secondary	Mean change in fasting GH and IGF-1 concentrations.		From baseline to 3, 6, and 12 months
Secondary	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
Secondary	Mean change in Quality of Life (QoL) scores	Assessed by the Acromegaly Quality of Life Questionnaire (AcroQoL).	From baseline to 6 and 12 months
Secondary	Treatment utilisation of LAN, evaluated by the total number of injections received		From baseline to 12 months
Secondary	Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI)		From baseline to 12 months
Secondary	Incidence of all Adverse Events (AEs)	Including Serious Adverse Events (SAEs) and special situations assessed according to incidence, intensity, causality, outcome, action taken, and seriousness.	From baseline to 3, 6 and 12 months
Secondary	Mean change in physical examination results	Including Body Mass Index (BMI) and weight	From baseline to 3, 6, and 12 months
Secondary	Mean change in vital signs blood pressure		From baseline to 3, 6, and 12 months
Secondary	Mean change in vital signs heart rate		From baseline to 3, 6, and 12 months
Secondary	Mean change in Clinical laboratory assessments	Including fasting blood glucose, glycated hemoglobin A1C (HbA1c), total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL, and triglycerides	From baseline to 6, and 12 months
Secondary	Mean change in free thyroxine (FT4) and cortisol for males and females		From baseline to 6 and 12 months
Secondary	Mean change in testosterone for males only		From baseline to 6 and 12 months
Secondary	Mean change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol for females only.		From baseline to 6 and 12 months