WithdrawnNCT01438801Updated Aug 5, 2019

Predictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF)

A Phase 4 interventional study of Nutropin [Somatropin (rDNA origin) for injection] in Idiopathic Short Stature, sponsored by Ipsen. Withdrawn. Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2019-08-05.

Sponsored by Ipsen · Phase 4, Interventional, and Diagnostic

Why this study was withdrawn

Participant enrollment was not feasible

Phase: Phase 4
Study type: Interventional
Enrollment: 0
Allocation: Not applicable
Ages: 2 Years to 10 Years
Sex: All

Study summary

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).

Conditions studied

Idiopathic Short Stature

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In context

Dwarfism

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Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 10 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age 2.0 - 9.0 years for females, 2.0 - 10.0 yrs for males.
Prepubertal stage (Tanner 1 for breast (B1) in females, or Tanner 1 for genitals (G1) for males).
Bone age \< 10 'years' (males) or \< 9 'years' (females) according to Greulich and Pyle. The bone age will be read by the pediatric endocrinologist responsible for the pre-study screening visit.
Height SDS \< -2.5 for ethnically adequate references. For children of Dutch or Western European origin the 1997 nation-wide references for Dutch children will be used. For children of Moroccan or Turkish origin, the respective reference charts will be used. For children of other ethnicities, the 1977 North American (NCHS/WHO) reference will be used, as these charts have been accepted by WHO as world-wide standard from the age of 5 years.

Exclusion criteria

Exclusion Criteria:

Has a history of hypersensitivity to growth hormone or phenol (conservative added to GH in NutropinAq), or drugs with a similar chemical structure.
Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
Has a birth weight and/or length below -2 SDS for Swedish reference charts. Patients will not be excluded due to an unknown birth weight or length.
Has a known cause of short stature, or any significant concomitant disease that is likely to interfere with growth or with the study schedule/objectives, or is a known contraindication to GH treatment.

Study design

Phase: Phase 4
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 0 participants (actual)

Study arms

Experimental
NutropinAq
Drug: Nutropin [Somatropin (rDNA origin) for injection]

Interventions

DrugNutropin [Somatropin (rDNA origin) for injection]
Doses in the diagnostic protocol are 0.7 and 1.4 mg/m2/day, injected by subcutaneous injection at bedtime for 2 weeks, divided by washout periods of preferably 4 weeks (accepted range 4-6 weeks). An additional period of 2 weeks on 2.8 mg/m2/day (after a washout period of 4-6 weeks) will be added if the IGF-I response on either dosage is insufficient (serum IGF-I SDS \<0).

What researchers measure

Primary outcomes

Peak serum IGF-1 level with GH (1.4 mg/m2/day) change from baseline.
Time frame: Week 2

Secondary outcomes

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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01438801
Lead sponsor: Ipsen
Responsible party: Sponsor
First posted: Sep 22, 2011
Start date: May 2013 (estimated)
Primary completion: May 31, 2013 (estimated)
Completion: May 31, 2013 (estimated)
Last update: Aug 5, 2019

Study contacts

Ipsen Medical Director, MD

study director · Ipsen

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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