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Predictive Factors Study (TAPAS)

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ClinicalTrials.gov Identifier: NCT02020499
Recruitment Status : Terminated (Poor enrolment)
First Posted : December 25, 2013
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date December 19, 2013
First Posted Date December 25, 2013
Last Update Posted Date January 14, 2019
Study Start Date August 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2013)
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline [ Time Frame: Baseline and 4 weeks ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 19, 2013)
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline [ Time Frame: Baseline, 1 year and 3 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Acromegaly
Intervention 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.
Study Groups/Cohorts Acromegalic patients
Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)
Intervention: Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: September 29, 2015)
5
Original Estimated Enrollment
 (submitted: December 19, 2013)
34
Actual Study Completion Date September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT02020499
Other Study ID Numbers A-9B-52030-265
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date January 2019