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

NCT ID: NCT05431803

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2024-12-13

Brief Summary

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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.

Detailed Description

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Conditions

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Acromegaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical, Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Peking Union Medical College Hospital (PUMCH)

Beijing, , China

Site Status

Peking University Third Hospital (PUH3)

Beijing, , China

Site Status

Xiangya Hospital Central South University (XYHCSU)

Changsha, , China

Site Status

West China Hospital,Sichuan University (WCH)

Chengdu, , China

Site Status

The First Affiliated Hospital,Sun Yat-sen University (FAHSYSU)

Guangzhou, , China

Site Status

The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)

Hangzhou, , China

Site Status

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School (NJDTH)

Nanjing, , China

Site Status

The First Hospital of China Medical University (CMU1H)

Shenyang, , China

Site Status

The Second Hospital of Hebei Medical University (HB2H)

Shijiazhuang, , China

Site Status

Affiliated Hospital of Wenzhou Medical University (FAHWMU)

Wenzhou, , China

Site Status

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology (TJH HUST)

Wuhan, , China

Site Status

The First Affiliated Hospital of Zhengzhou University (FAHZZU)

Zhengzhou, , China

Site Status

Countries

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China

Other Identifiers

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CLIN-52030-455

Identifier Type: -

Identifier Source: org_study_id

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