Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly

Acromegaly Clinical Trial

— PLAN-A  

Official title:

Non-interventional, Prospective Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04003519
• Other study ID #: A-DE-52030-368
• Status: Withdrawn
• Start date: April 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Predictors of change in IGF-I between baseline compared to visit 4 and baseline compared to LVA.		baseline and 12 months
Secondary	Predictors of change in random GH-levels between baseline compared to visit 4 and baseline compared to LVA		baseline and 12 months
Secondary	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
Secondary	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
Secondary	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