AcromegalyTAPASNCT02020499
Predictive Factors Study
An observational study of Acromegaly, run by Ipsen at 6 sites in Australia.
Trial summary
This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Somatuline Autogel® (lanreotide) 60, 90, 120 mg.
- How many people
- 5 participants
- Where
- 6 sitesAustralia
- Study dates
- Aug 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
St Vincent's Hospital
Darlinghurst, New South Wales, 2010
St Vincent's Hospital
Fitzroy, Victoria, 3065
The Austin Hospital
Heidelberg, Victoria, 3084
Royal Brisbane & Women's Hospital
Herston, Queensland, 4006
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this 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.
This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.
- Conditions
- Acromegaly
- Being tested
- Somatuline Autogel® (lanreotide) 60, 90, 120 mg.
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatuline Autogel® (lanreotide) 60, 90, 120 mg.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.
| Study group | Role | What they receive |
|---|---|---|
| Acromegalic patients | Acromegalic subjects treated with Somatuline Autogel® (Lanreotide) Receives: Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
Measured: Baseline and 4 weeks
Secondary outcomes (1)
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
Measured: Baseline, 1 year and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Poor enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020499
- Sponsor's protocol ID
- A-9B-52030-265
- Acronym
- TAPAS
- Status last verified
- Jan 2019
- First submitted
- 19 Dec 2013
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02020499
- Acronym / sponsor ID
- TAPAS / A-9B-52030-265
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor enrolment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acromegalic patients | – | Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.Acromegalic subjects treated with Somatuline Autogel® (Lanreotide) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Acromegalic patients |
Primary outcome
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
Time frame: Baseline and 4 weeks
1 secondary outcome
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
Time frame: Baseline, 1 year and 3 years
Results and safety
The study was stopped early (reason given: Poor enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
Related trials for Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
Not yet recruitingPhase 3
PRESTO: A Phase III Randomised Controlled Trial of Dose-escalated Proton Beam Therapy Versus Standard of Care Radiotherapy for Functioning Pituitary Tumours
Acromegaly Due to Pituitary Adenoma, Cushing's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Ipsen at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor enrolment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.