Primary Insulin-like Growth Factor-1 DeficiencyNCT00747604
IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
An observational study of Primary Insulin-like Growth Factor-1 Deficiency, run by Ipsen at 1 site in United States.
Trial summary
This project is a retrospective (beginning January 2006) and prospective patient registry program sponsored by Ipsen (formerly Tercica, Inc.). In collaboration with participating health care practitioners, the patient registry program is an observational study monitoring the long-term safety of patients treated with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Insulin-like Growth Factor-1 Deficiency
- What is being tested?
- mecasermin [rDNA origin] injection
- Type of treatment
- Injection or infusion
- How many people
- 1,378 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to May 2014
- How long will I take part?
- 8 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex.
Who may be able to join
- Parents or legally authorized representatives must give signed informed consent before any Registry-related activities are conducted. Assent from the subject should also be obtained where appropriate.
- Patients receiving Increlex® by a qualified practitioner may be enrolled
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ipsen Central Contact
Basking Ridge, New Jersey, 07920
About this study
Official title: Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
This project is a retrospective (beginning January 2006) and prospective patient registry program sponsored by Ipsen (formerly Tercica, Inc.). In collaboration with participating health care practitioners, the patient registry program is an observational study monitoring the long-term safety of patients treated with Increlex® (mecasermin [rDNA origin] injection). The IGFD (Increlex® Growth Forum Database) Registry is intended primarily to monitor the safety and efficacy of Increlex replacement therapy in children with growth failure.
Read the detailed description
The data collected for a patient will be those that exist in the patient's medical record as part of standard medical care. No additional patient procedures or activities are mandated by this study. The specific data to be collected at each visit and the schedule of data collection are listed in a schedule of assessments.
The collection of safety events is considered essential to the Registry. The website will provide the opportunity to report the occurrence of targeted adverse events (AEs), other important events considered to be related to Increlex administration and serious adverse events (SAEs).
- Being tested
- mecasermin [rDNA origin] injection
- Keywords
- Growth Hormone (GH) Insensitivity Syndrome, Insulin-like Growth Factor Deficiency (IGFD), Short Stature, Insulin-like Growth Factor (IGF-1), Growth
- Medical subject headings
- Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mecasermin [rDNA origin] injectionBiological
Also called Increlex®
As prescribed by the physician.
| Study group | Role | What they receive |
|---|---|---|
| Increlex patients | Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex. Receives: Biological: mecasermin [rDNA origin] injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain long-term safety and efficacy data for Increlex® replacement therapy in children with growth failure
Measured: periodically assessed over the course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startJun 2006
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Shortage of Increlex supply
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Insulin-like Growth Factor-1 DeficiencyStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 1,378 participants (actual)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Endocrinology, Study director, Ipsen (formerly Tercica)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747604
- Sponsor's protocol ID
- W-TG-52800-010 (MS305)
- Status last verified
- Nov 2020
- First submitted
- 3 Sep 2008
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
- ClinicalTrials.gov ID
- NCT00747604
- Acronym / sponsor ID
- W-TG-52800-010 (MS305)
- Keywords
- Growth Hormone (GH) Insensitivity Syndrome, Insulin-like Growth Factor Deficiency (IGFD), Short Stature, Insulin-like Growth Factor (IGF-1), Growth
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Shortage of Increlex supply
- Enrolment
- 1,378 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 5 Sep 2008 (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 project is a retrospective (beginning January 2006) and prospective patient registry program sponsored by Ipsen (formerly Tercica, Inc.). In collaboration with participating health care practitioners, the patient registry program is an observational study monitoring the long-term safety of patients treated with Increlex® (mecasermin [rDNA origin] injection). The IGFD (Increlex® Growth Forum Database) Registry is intended primarily to monitor the safety and efficacy of Increlex replacement therapy in children with growth failure.
Detailed description
The data collected for a patient will be those that exist in the patient's medical record as part of standard medical care. No additional patient procedures or activities are mandated by this study. The specific data to be collected at each visit and the schedule of data collection are listed in a schedule of assessments.
The collection of safety events is considered essential to the Registry. The website will provide the opportunity to report the occurrence of targeted adverse events (AEs), other important events considered to be related to Increlex administration and serious adverse events (SAEs).
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 8 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Increlex patients | – | Biological: mecasermin [rDNA origin] injectionEligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex.
Key inclusion criteria (2 listed)
- Parents or legally authorized representatives must give signed informed consent before any Registry-related activities are conducted. Assent from the subject should also be obtained where appropriate.
- Patients receiving Increlex® by a qualified practitioner may be enrolled
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| mecasermin [rDNA origin] injectionAlso: Increlex®As prescribed by the physician. | Biological | Increlex patients |
Primary outcome
To obtain long-term safety and efficacy data for Increlex® replacement therapy in children with growth failure
Time frame: periodically assessed over the course of the study
Results and safety
The study was stopped early (reason given: Shortage of Increlex supply). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
Related trials for Primary Insulin-like Growth Factor-1 Deficiency
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.
Medical Director, Endocrinology study director
Ipsen (formerly Tercica)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Insulin-like Growth Factor-1 Deficiency, run by Ipsen at 1 site in United States.
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 2 inclusion and 0 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 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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: Shortage of Increlex supply). 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?
To obtain long-term safety and efficacy data for Increlex® replacement therapy in children with growth failure (time frame: periodically assessed over the course of the study). 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 6 Nov 2020.