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Predictive Factors Study (TAPAS)

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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.

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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