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

• Sponsor: Ipsen (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05431803
• Collaborator: (none)
• Enrollment: 210
• Locations: 12
• Anticipated Duration (Months): 35
• Patients Per Site: 17.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acromegaly

Study Design

• Study Type: Observational
• Anticipated Enrollment: 210 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Real-World Study of Lanreotide Autogel for the Treatment of Patients With Acromegaly in China
• Actual Study Start Date: Jun 30, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: May 31, 2025

Outcome Measures

Primary Outcome Measures

1. 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

1. Percentage of participants achieving fasting GH < 1 μg/L and IGF-1 normalization [At 12 months]

2. Percentage of participants achieving fasting GH ≤2.5 μg/L and IGF-1 ≤1.3 Upper Limit of Normal (ULN) [At 12 months]

3. Mean change in fasting GH and IGF-1 concentrations. [From baseline to 3, 6, and 12 months]

4. 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]

5. Mean change in Quality of Life (QoL) scores [From baseline to 6 and 12 months]

   Assessed by the Acromegaly Quality of Life Questionnaire (AcroQoL).

6. Treatment utilisation of LAN, evaluated by the total number of injections received [From baseline to 12 months]

7. Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI) [From baseline to 12 months]

8. 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.

9. Mean change in physical examination results [From baseline to 3, 6, and 12 months]

   Including Body Mass Index (BMI) and weight

10. Mean change in vital signs blood pressure [From baseline to 3, 6, and 12 months]

11. Mean change in vital signs heart rate [From baseline to 3, 6, and 12 months]

12. 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

13. Mean change in free thyroxine (FT4) and cortisol for males and females [From baseline to 6 and 12 months]

14. Mean change in testosterone for males only [From baseline to 6 and 12 months]

15. Mean change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol for females only. [From baseline to 6 and 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing		China	100000
2	Peking University Third Hospital	Beijing		China	100000
3	Xiangya Hospital Central South University	Changsha		China	410000
4	West China Hospital，Sichuan University	Chengdu		China	610000
5	The First Affiliated Hospital,Sun Yat-sen University	Guangzhou		China	510000
6	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou		China	310000
7	Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School	Nanjing		China	210000
8	The First Hospital of China Medical University	Shenyang		China	110000
9	The Second Hospital of Hebei Medical University	Shijiazhuang		China	050000
10	The 1st School of Medicine, The 1st Affiliated Hospital of WMU	Wenzhou		China	325000
11	Tongji Medical College of HUST	Wuhan		China	430000
12	The First Affiliated Hospital of Zhengzhou University	Zhengzhou		China	450000

Sponsors and Collaborators

• Ipsen

Investigators

• Study Director: Ipsen Medical, Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ipsen
• ClinicalTrials.gov Identifier: NCT05431803
• Other Study ID Numbers: CLIN-52030-455
• First Posted: Jun 24, 2022
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acromegaly

Study Results

No Results Posted as of Jul 14, 2022