Study Stopped
Study timeline delay, low site feasibility and delay concerns due to COVID-19.
Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly
PLAN-A
Non-interventional, Prospective Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly
1 other identifier
observational
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2020
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2019
CompletedFirst Posted
Study publicly available on registry
July 1, 2019
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedJune 2, 2020
June 1, 2020
3.2 years
June 27, 2019
June 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
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
- +6 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Participation in an interventional trial at the same time and/or within 3 months before baseline
- Subject represented by a legal guardian
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2019
First Posted
July 1, 2019
Study Start
April 1, 2020
Primary Completion
June 30, 2023
Study Completion
December 30, 2023
Last Updated
June 2, 2020
Record last verified: 2020-06