Predictive Factors Study

NCT ID: NCT02020499

Last Updated: 2019-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-09-30

Brief Summary

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

Detailed Description

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Conditions

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Acromegaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acromegalic patients

Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)

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

Intervention Type DRUG

Patients receiving treatment as prescribed by the investigator and according to current treatment recommendations and routine clinical practice, and in line with local regulations.

Interventions

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

Patients receiving treatment as prescribed by the investigator and according to current treatment recommendations and routine clinical practice, and in line with local regulations.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Site Status

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Site Status

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia

Site Status

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status

St Vincent's Hospital

Fitzroy, Victoria, Australia

Site Status

The Austin Hospital

Heidelberg, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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A-9B-52030-265

Identifier Type: -

Identifier Source: org_study_id

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