Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

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

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 Type

Observational

Primary Outcome

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.

Secondary Outcome

 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

Condition

Acromegaly

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

0

Start Date

April 2020

Completion Date

December 30, 2023

Primary Completion Date

June 30, 2023

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Administrative Informations

NCT ID

NCT04003519

Organization ID

A-DE-52030-368

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

June 2020