Clinical trial NCT05431803: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2022-06-24
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants who have been diagnosed with acromegaly and initiating LAN treatment

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.


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

Primary outcomes:
measure: Percentage of participants achieving full biochemical control
timeFrame: At 12 months
Secondary outcomes:
measure: Percentage of participants achieving fasting GH < 1 μg/L and IGF-1 normalization
timeFrame: At 12 months
measure: Percentage of participants achieving fasting GH ≤2.5 μg/L and IGF-1 ≤1.3 Upper Limit of Normal (ULN)
timeFrame: At 12 months
measure: Mean change in fasting GH and IGF-1 concentrations.
timeFrame: From baseline to 3, 6, and 12 months
measure: 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.
timeFrame: From baseline to 6 and 12 months
measure: Mean change in Quality of Life (QoL) scores
timeFrame: From baseline to 6 and 12 months
measure: Treatment utilisation of LAN, evaluated by the total number of injections received
timeFrame: From baseline to 12 months
measure: Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI)
timeFrame: From baseline to 12 months
measure: Incidence of all Adverse Events (AEs)
timeFrame: From baseline to 3, 6 and 12 months
measure: Mean change in physical examination results
timeFrame: From baseline to 3, 6, and 12 months
measure: Mean change in vital signs blood pressure
timeFrame: From baseline to 3, 6, and 12 months
measure: Mean change in vital signs heart rate
timeFrame: From baseline to 3, 6, and 12 months
measure: Mean change in Clinical laboratory assessments
timeFrame: From baseline to 6, and 12 months
measure: Mean change in free thyroxine (FT4) and cortisol for males and females
timeFrame: From baseline to 6 and 12 months
measure: Mean change in testosterone for males only
timeFrame: From baseline to 6 and 12 months
measure: Mean change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol for females only.
timeFrame: From baseline to 6 and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital (PUMCH)
city: Beijing
country: China
facility: Peking University Third Hospital (PUH3)
city: Changsha
country: China
facility: Xiangya Hospital Central South University (XYHCSU)
city: Chengdu
country: China
facility: West China Hospital，Sichuan University (WCH)
city: Guangzhou
country: China
facility: The First Affiliated Hospital,Sun Yat-sen University (FAHSYSU)
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School (NJDTH)
city: Shenyang
country: China
facility: The First Hospital of China Medical University (CMU1H)
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University (HB2H)
city: Wenzhou
country: China
facility: Affiliated Hospital of Wenzhou Medical University (FAHWMU)
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology (TJH HUST)
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University (FAHZZU)
Study officials:
affiliation: Ipsen
name: Ipsen Medical, Director
role: STUDY_DIRECTOR
References: