Predictive Factors Study (TAPAS)

Ipsen

Status: Terminated

Conditions: Acromegaly

Treatments: Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.

Study type: Observational

Funder types: Industry

Identifiers

NCT02020499

A-9B-52030-265

Details and patient eligibility

About

This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

5 participants in 1 patient group

Acromegalic patients

Description:

Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)

Treatment:

Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.