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
Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly
Status
Withdrawn
Phase
Not applicable
Enrollment
0
Locations
0
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
No intervention details reported.
Timeline
From registration to results.
First posted
Jul 1, 2019
Study start
Apr 2020
Primary completion
Jun 30, 2023
Study completion
Dec 30, 2023
Results posted
Not reported
Registry updated
Jun 2, 2020
Outcomes
What the study measures.
Primary outcomes
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
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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.
Time frame · 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.
Time frame · baseline and 12 months
Predictors of change in IGF-I between baseline compared to visit 4 and baseline compared to LVA.
Time frame · baseline and 12 months
Predictors of change in random GH-levels between baseline compared to visit 4 and baseline compared to LVA
Time frame · baseline and 12 months
Patient's global impression of change (PGIC)
Time frame · 3, 6, 12 and 18 months
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
Changes in signs and symptoms (Numerical Rating Scale), patient's global impression of change (PGIC)
Time frame · Baseline, 3, 6, 12 and 18 months
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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
Study locations
0 registered sites.
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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