Trial · Interventional
WithdrawnPhase 4Registry dataPredictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF)
This trial was withdrawn before it enrolled anyone.
Reason given at the registry: Participant enrollment was not feasible
Overview
- Status
- Withdrawn
- Phase
- Phase 4
- Enrollment
- 0 participants (actual)
- Sponsor
- Ipsen · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
- Not stated
- Start
- May 2013 (estimated)
- Primary completion
- 31 May 2013 (estimated)
- Completion
- 31 May 2013 (estimated)
- First posted
- 22 Sept 2011 (estimated)
- Last update posted
- 5 Aug 2019
- Conditions
- Idiopathic Short Stature
Timeline
1 trial · 1 stopped early
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4Withdrawn
Predictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF)
NCT01438801est. May 2013 to est. 31 May 2013
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The evaluation of a standardized diagnostic test to predict the growth response in a 1 year trial with Growth Hormone (GH) treatment (carried out in the context of regular patient care) in non GH deficient short children with low serum insulin-like growth factor-1 (IGF-1).
Interventions
- Nutropin [Somatropin (rDNA origin) for injection]Drug
Arms1
Experimental
NutropinAq
Primary outcomes1
Outcomes the sponsor listed as primary.
Peak serum IGF-1 level with GH (1.4 mg/m2/day) change from baseline.
Time frame · Week 2
Secondary outcomes(7)
Delta IGF-1 SDS on 0.7 & 1.4 mg GH/m2/day
Time frame · Baseline, week 2
Delta insulin-like growth factor binding protein-3 (IGFBP-3) standard deviation score (SDS) on 0.7 & 1.4 mg GH/m2/day
Time frame · Baseline, week 2
Delta of the ratio IGF-1:IGFBP-3 SDS on 0.7 mg & 1.4 mg GH/m2/day
Time frame · Baseline, week 2
Delta of the ratio IGF-1:IGFBP-2 (insulin-like growth factor binding protein-2) SDS on 0.7 mg & 1.4 mg GH/m2/day
Time frame · Baseline, week 2
Peak IGFBP-3 SDS on 0.7 mg & 1.4 mg GH/m2/day
Time frame · Baseline, week 2
Peak of the ratio IGF-1:IGFBP-3 SDS on 0.7 mg & 1.4 mg GH/m2/day
Time frame · Baseline, week 2
Peak of the ratio IGF-1:IGFBP-2 SDS on 0.7 mg & 1.4 mg GH/m2/day
Time frame · Baseline, week 2
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 2 Years up to 10 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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