Clinical trial NCT04003519: Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly
Official title: Non-interventional, Prospective Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 3 , 6 and 18 months
measure: Changes from baseline of centrally assessed IGF-I levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel
timeFrame: 3, 6, 12 and 18 months
measure: Changes from baseline of centrally assessed random GH-levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel
timeFrame: 3, 6, 12 and 18 months
measure: Changes from baseline of centrally assessed GH-BP levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel
timeFrame: 3, 6, 12 and 18 months
measure: 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.
timeFrame: 3, 6, 12 and 18 months
measure: 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.
timeFrame: baseline and 12 months
measure: Predictors of change in IGF-I between baseline compared to visit 4 and baseline compared to LVA.
timeFrame: baseline and 12 months
measure: Predictors of change in random GH-levels between baseline compared to visit 4 and baseline compared to LVA
timeFrame: baseline and 12 months
measure: Patient's global impression of change (PGIC)
timeFrame: 3, 6, 12 and 18 months
measure: Changes in signs and symptoms (Numerical Rating Scale), patient's global impression of change (PGIC)
timeFrame: Baseline, 3, 6, 12 and 18 months
measure: Quality of life between baseline and visits 2, 3, 4 and 5.
timeFrame: Baseline, 3, 6, 12 and 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: