Predictive Factors Study (TAPAS)

January 11, 2019 updated by: Ipsen

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Royal Brisbane & Women's Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital
      • Heidelberg, Victoria, Australia, 3084
        • The Austin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult subjects in hospitals and private practices, suffering from acromegaly who are scheduled to receive ATG or already on treatment with ATG for a maximum of 3 months.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acromegalic patients
Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
Time Frame: Baseline, 1 year and 3 years
Baseline, 1 year and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 25, 2013

Study Record Updates

Last Update Posted (Actual)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-9B-52030-265

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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