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

April 2, 2024 updated by: Ipsen

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100000
        • Peking Union Medical College Hospital (PUMCH)
      • Beijing, China, 100000
        • Peking University Third Hospital (PUH3)
      • Changsha, China, 410000
        • Xiangya Hospital Central South University (XYHCSU)
      • Chengdu, China, 610000
        • West China Hospital，Sichuan University (WCH)
      • Guangzhou, China, 510000
        • The First Affiliated Hospital,Sun Yat-sen University (FAHSYSU)
      • Hangzhou, China, 310000
        • The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
      • Nanjing, China, 210000
        • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School (NJDTH)
      • Shenyang, China, 110000
        • The First Hospital of China Medical University (CMU1H)
      • Shijiazhuang, China, 050000
        • The Second Hospital of Hebei Medical University (HB2H)
      • Wenzhou, China, 325000
        • Affiliated Hospital of Wenzhou Medical University (FAHWMU)
      • Wuhan, China, 430000
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology (TJH HUST)
      • Zhengzhou, China, 450000
        • The First Affiliated Hospital of Zhengzhou University (FAHZZU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants who have been diagnosed with acromegaly and initiating LAN treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving fasting GH < 1 μg/L and IGF-1 normalization
Time Frame: At 12 months
At 12 months
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
At 12 months
Mean change in fasting GH and IGF-1 concentrations.
Time Frame: From baseline to 3, 6, and 12 months
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.
Time Frame: From baseline to 6 and 12 months
From baseline to 6 and 12 months
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).
From baseline to 6 and 12 months
Treatment utilisation of LAN, evaluated by the total number of injections received
Time Frame: From baseline to 12 months
From baseline to 12 months
Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI)
Time Frame: From baseline to 12 months
From baseline to 12 months
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.
From baseline to 3, 6 and 12 months
Mean change in physical examination results
Time Frame: From baseline to 3, 6, and 12 months
Including Body Mass Index (BMI) and weight
From baseline to 3, 6, and 12 months
Mean change in vital signs blood pressure
Time Frame: From baseline to 3, 6, and 12 months
From baseline to 3, 6, and 12 months
Mean change in vital signs heart rate
Time Frame: From baseline to 3, 6, and 12 months
From baseline to 3, 6, and 12 months
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
From baseline to 6, and 12 months
Mean change in free thyroxine (FT4) and cortisol for males and females
Time Frame: From baseline to 6 and 12 months
From baseline to 6 and 12 months
Mean change in testosterone for males only
Time Frame: From baseline to 6 and 12 months
From baseline to 6 and 12 months
Mean change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol for females only.
Time Frame: From baseline to 6 and 12 months
From baseline to 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Investigators

  • Study Director: Ipsen Medical, Director, Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-52030-455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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.

IPD Sharing Access Criteria

Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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