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Study timeline delay, low site feasibility and delay concerns due to COVID-19.
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The purpose of the study is to collect data about predictive factors for the efficacy of Lanreotide Autogel in patients with acromegaly in routine clinical practice.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with normalization of centrally assessed age and sex adjusted IGF-I levels at visit 4 (about 12 months) after treatment start with lanreotide autogel. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with normalization of centrally assessed age- and sex-adjusted IGF-I levels at visit 2, 3, and 5 after treatment start with lanreotide autogel | 3 , 6 and 18 months | |
| Changes from baseline of centrally assessed IGF-I levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects with biochemically active acromegaly, without previous treatment (medical treatment or radiotherapy) except for surgery and/or dopamine agonists (treatment terminated at or before baseline) who are already planned within the medical routine to be treated with lanreotide autogel.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| 3, 6, 12 and 18 months |
| Changes from baseline of centrally assessed random GH-levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel | 3, 6, 12 and 18 months |
| Changes from baseline of centrally assessed GH-BP levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel | 3, 6, 12 and 18 months |
| Proportion of subjects with GH-normalization - defined as centrally assessed random GH-levels (GH < 1 μg/L) - at visits 2, 3, 4, and 5 during treatment with lanreotide autogel. | 3, 6, 12 and 18 months |
| Predictors for reduction of age- and sex-adjusted IGF-I to normal levels (control of acromegaly) at visits 4 compared to baseline and Last Visit Available (LVA) compared to baseline. | baseline and 12 months |
| Predictors of change in IGF-I between baseline compared to visit 4 and baseline compared to LVA. | baseline and 12 months |
| Predictors of change in random GH-levels between baseline compared to visit 4 and baseline compared to LVA | baseline and 12 months |
| Patient's global impression of change (PGIC) | Scale is used to assess the validity of Patient Global Impression of Change (PGIC). the score ranges between 1= very much worse and 7 = very much improved | 3, 6, 12 and 18 months |
| Changes in signs and symptoms (Numerical Rating Scale), patient's global impression of change (PGIC) | It will be measured using Numerical Rating Scale to assess the average presence or severity of the symptoms. The score ranges from 0 = no symptom at all to 10 = maximum intensity of the symptom | Baseline, 3, 6, 12 and 18 months |
| Quality of life between baseline and visits 2, 3, 4 and 5. | Measured by a generic, multipurpose short-form survey with 12 questions (SF-12). Scale provides information about mental and physical functioning and overall health-related-QoL. ". Higher scores indicate a better QoL. | Baseline, 3, 6, 12 and 18 months |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |