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Long-Term Treatment With rhIGF-1 in GHIS
Plain-language guide to NCT00571727: phase 2, phase 3 interventional trial of IGF-1 LR3 and Mecasermin (rhIGF-1), 92 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00571727
- Phase
- phase 2, phase 3
- Status
- completed
- Start
- 1991-05-20
- Completion (planned or actual)
- 2011-12-15
- Participants
- 92 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Growth Hormone Insensitivity Syndrome
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2, phase 3) is built around IGF-1 LR3 and Mecasermin (rhIGF-1).
It had 1 arm (groups): mecasermin, injections BID of rhIGF-1 (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 92 actual participants took part.
It was open to people of any sex aged from 2 years up to 21 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Height \<-2SD for age and gender. IGF-1 \<-2SD for age and gender. Evidence of GH resistance.
The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: closed epiphyses; prior active malignancy; major organ disfunction.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when IGF-1 LR3 was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 1991-05-20 with completion listed for 2011-12-15.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Annualized Height Velocity Up to 12 Years. Number of Naive Participants With Height Velocity <5 cm/y at the End of 1 Year of Study Treatment.
It also tracked 3 secondary outcomes, for example Height Velocity Standard Deviation Score Up to 12 Years and Height Standard Deviation Score Up to 12 Years.
What This Means in Plain Language
Put simply, this is a phase 2, phase 3 trial of IGF-1 LR3 and Mecasermin (rhIGF-1) in 92 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the IGF-1 LR3 compound page and the Mecasermin (rhIGF-1) compound page, all human trials.
Our Notes on the Compounds
IGF-1 LR3: A modified IGF-1 analog that escapes binding proteins, so it stays active ≥24 h.
Mecasermin (rhIGF-1): FDA-approved recombinant human IGF-1 for severe primary IGF-1 deficiency in children; distinct from IGF-1 LR3 and IGF-1 DES.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.