Acromegaly
Conditions
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.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving fasting GH ≤2.5 μg/L and IGF-1 ≤1.3 Upper Limit of Normal (ULN) | At 12 months | — |
| Mean change in fasting GH and IGF-1 concentrations. | 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. | From baseline to 6 and 12 months | — |
| Mean change in Quality of Life (QoL) scores | From baseline to 6 and 12 months | Assessed by the Acromegaly Quality of Life Questionnaire (AcroQoL). |
| Treatment utilisation of LAN, evaluated by the total number of injections received | From baseline to 12 months | — |
| Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI) | From baseline to 12 months | — |
| 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. |
| Percentage of participants achieving fasting GH < 1 μg/L and IGF-1 normalization | At 12 months | — |
| Mean change in vital signs blood pressure | From baseline to 3, 6, and 12 months | — |
| Mean change in free thyroxine (FT4) and cortisol for males and females | From baseline to 6 and 12 months | — |
| Mean change in vital signs heart rate | From baseline to 3, 6, and 12 months | — |
| 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 |
| Mean change in testosterone for males only | From baseline to 6 and 12 months | — |
| Mean change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol for females only. | From baseline to 6 and 12 months | — |
| Mean change in physical examination results | From baseline to 3, 6, and 12 months | Including Body Mass Index (BMI) and weight |
Countries
China
Outcome results
None listed