Predictive Factors Study

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Acromegaly
Related Access Program
Novartis Pharmaceuticals – Acromegaly
Related Clinical Trial
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Brief Title

Predictive Factors Study

Official Title

Non-interventional, Observational, Long Term Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel (ATG) Treatment in Patients With Acromegaly.

Brief Summary

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

Study Type

Observational

Primary Outcome

Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline

Secondary Outcome

 Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline

Condition

Acromegaly

Intervention

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

Study Arms / Comparison Groups

 Acromegalic patients
Description:  Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)

Publications

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

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

5

Start Date

August 2014

Completion Date

September 2015

Primary Completion Date

September 2015

Eligibility 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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT02020499

Organization ID

A-9B-52030-265

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

January 2019