NCT04003519WithdrawnNot Applicable
Non-interventional, Prospective Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Ipsen
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female aged 18 years and older with the capacity to consent
- •Signed written informed consent
- •Subject with hormonally active acromegaly defined by locally measured IGF-I levels 1.3 times above the age- and sex-adjusted normal range as determined at the last routine visit before baseline and after surgery
- •Subject with the intention to be treated with lanreotide autogel according to the current local SmPC (Germany, Austria) prior to study enrolment
Exclusion Criteria
- •Participation in an interventional trial at the same time and/or within 3 months before baseline
- •Subject represented by a legal guardian
Outcomes
Primary Outcomes
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.
Time Frame: 12 months
Secondary Outcomes
- 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(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)(3, 6, 12 and 18 months)
- Changes in signs and symptoms (Numerical Rating Scale), patient's global impression of change (PGIC)(Baseline, 3, 6, 12 and 18 months)
- Quality of life between baseline and visits 2, 3, 4 and 5.(Baseline, 3, 6, 12 and 18 months)
Investigators
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