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

Ipsen129 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

129

Conditions

Acromegaly

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Peking Union Medical College Hospital (PUMCH)

Beijing, China

Peking University Third Hospital (PUH3)

Beijing, China

Xiangya Hospital Central South University (XYHCSU)

Changsha, China

Outcomes

Primary Outcomes

Percentage of participants achieving full biochemical control

Defined as fasting Growth Hormone (GH) ≤ 2.5 μg/L and Insulin-like Growth Factor-1 (IGF-1) normalization

Time frame: At 12 months

Secondary Outcomes

Percentage of participants achieving fasting GH < 1 μg/L and IGF-1 normalization

Time frame: 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

Mean change in fasting GH and IGF-1 concentrations.

Time frame: 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

Mean change in Quality of Life (QoL) scores

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

Time frame: 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

Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI)

Time frame: From baseline to 12 months

Incidence of all Adverse Events (AEs)

Including Serious Adverse Events (SAEs) and special situations assessed according to incidence, intensity, causality, outcome, action taken, and seriousness.

Data from ClinicalTrials.gov

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