Overview

Predictive Factors Study

Status:
Terminated
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
Summary
This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ipsen
Treatments:
Angiopeptin
Lanreotide
Somatostatin
Criteria
Inclusion Criteria:

- Diagnosis of Acromegaly.

- Males and females aged 18 years and older.

- Signed informed consent (patient must give consent to the collection of retrospective
data).

- Patients who have had surgery may enter the study 3 months post-surgery and evaluated
for the duration of the study.

- With the intention to be treated with ATG (decision to prescribe ATG made prior to
inclusion into the study) or already being treated with ATG.

- If already being treated with ATG:

Previous ATG treatment maximum of 3 months. AND Minimum data available (demographic data,
disease history including previous treatments, GH, IGF-1 levels at baseline and under
treatment as applicable).

- Not receiving Dopamine Agonists or other medical therapy (Pegvisomant, or other
somatostatin analogues) for the treatment or symptom control of acromegaly.

Exclusion Criteria:

- The subject has had radiotherapy in the last 5 years.

- The subject has had surgery in the last 3 months.

- The subject has already been included in this study.

- Participation in an interventional trial, or receiving experimental drug.