Overview

This trial is active, not recruiting.

Conditions acromegaly, neuroendocrine tumours
Treatment somatuline autogel® 60, 90 or 120 mg
Sponsor Ipsen
Start date June 2012
End date December 2016
Trial size 156 participants
Trial identifier NCT01840449, A-94-52030-240

Summary

The aim of the study is to identify predictive factors for the response to Lanreotide treatment in Acromegaly as well as in Neuroendocrine Tumours.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.
somatuline autogel® 60, 90 or 120 mg
The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.
somatuline autogel® 60, 90 or 120 mg

Primary Outcomes

Measure
Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)
time frame: Baseline and 1 year

Secondary Outcomes

Measure
Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)
time frame: Baseline and 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Written informed consent (also mandatory in case of retrospective documentation of subject data) - Diagnosis of acromegaly or NET with the intention to be treated with ATG or already on treatment with ATG Exclusion Criteria: - The subject has already been included in this study - Participation in an interventional trial

Additional Information

Official title Non-interventional, Observational Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel® (ATG) Treatment in Subjects With Either Acromegaly or Neuroendocrine Tumours (NET)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Ipsen.