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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05431803
Recruitment Status : Recruiting
First Posted : June 24, 2022
Last Update Posted : December 13, 2022
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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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
Acromegaly

Study Design
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Study Type : Observational
Estimated 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 : June 30, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants achieving full biochemical control [ Time Frame: 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 [ Time Frame: At 12 months ]
  2. Percentage of participants achieving fasting GH ≤2.5 μg/L and IGF-1 ≤1.3 Upper Limit of Normal (ULN) [ Time Frame: At 12 months ]
  3. Mean change in fasting GH and IGF-1 concentrations. [ Time Frame: 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. [ Time Frame: From baseline to 6 and 12 months ]
  5. Mean change in Quality of Life (QoL) scores [ Time Frame: 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 [ Time Frame: From baseline to 12 months ]
  7. Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI) [ Time Frame: From baseline to 12 months ]
  8. Incidence of all Adverse Events (AEs) [ Time Frame: 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 [ Time Frame: From baseline to 3, 6, and 12 months ]
    Including Body Mass Index (BMI) and weight

  10. Mean change in vital signs blood pressure [ Time Frame: From baseline to 3, 6, and 12 months ]
  11. Mean change in vital signs heart rate [ Time Frame: From baseline to 3, 6, and 12 months ]
  12. Mean change in Clinical laboratory assessments [ Time Frame: 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 [ Time Frame: From baseline to 6 and 12 months ]
  14. Mean change in testosterone for males only [ Time Frame: From baseline to 6 and 12 months ]
  15. Mean change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol for females only. [ Time Frame: From baseline to 6 and 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult participants who have been diagnosed with acromegaly and initiating LAN treatment
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05431803


Contacts
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Contact: Ipsen Recruitment Enquiries see email clinical.trials@ipsen.com

Locations
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China
Peking Union Medical College Hospital (PUMCH) Recruiting
Beijing, China, 100000
Peking University Third Hospital (PUH3) Not yet recruiting
Beijing, China, 100000
Xiangya Hospital Central South University (XYHCSU) Not yet recruiting
Changsha, China, 410000
West China Hospital，Sichuan University (WCH) Recruiting
Chengdu, China, 610000
The First Affiliated Hospital,Sun Yat-sen University (FAHSYSU) Recruiting
Guangzhou, China, 510000
The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU) Recruiting
Hangzhou, China, 310000
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School (NJDTH) Recruiting
Nanjing, China, 210000
The First Hospital of China Medical University (CMU1H) Not yet recruiting
Shenyang, China, 110000
The Second Hospital of Hebei Medical University (HB2H) Active, not recruiting
Shijiazhuang, China, 050000
Affiliated Hospital of Wenzhou Medical University (FAHWMU) Recruiting
Wenzhou, China, 325000
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology (TJH HUST) Recruiting
Wuhan, China, 430000
The First Affiliated Hospital of Zhengzhou University (FAHZZU) Not yet recruiting
Zhengzhou, China, 450000
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical, Director Ipsen
More Information
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT05431803    
Other Study ID Numbers: CLIN-52030-455
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: December 13, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.
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/).
URL: https://vivli.org/members/ourmembers/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases