Skip to content

Trial · Interventional

WithdrawnPhase 4Registry data

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

NCTNCT01438801 (opens ClinicalTrials.gov in a new tab)Other idA-95-58035-017Other id2010-019980-13

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Withdrawn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
20132014
  1. Ph 4

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

    NCT01438801

    est. May 2013 to est. 31 May 2013

    Withdrawn

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.

  1. Peak serum IGF-1 level with GH (1.4 mg/m2/day) change from baseline.

    Time frame · Week 2

Secondary outcomes(7)
  1. Delta IGF-1 SDS on 0.7 & 1.4 mg GH/m2/day

    Time frame · Baseline, week 2

  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

  3. Delta of the ratio IGF-1:IGFBP-3 SDS on 0.7 mg & 1.4 mg GH/m2/day

    Time frame · Baseline, week 2

  4. 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

  5. Peak IGFBP-3 SDS on 0.7 mg & 1.4 mg GH/m2/day

    Time frame · Baseline, week 2

  6. Peak of the ratio IGF-1:IGFBP-3 SDS on 0.7 mg & 1.4 mg GH/m2/day

    Time frame · Baseline, week 2

  7. 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
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: * 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.

PepBank is a research reference. Talk to a doctor before you use any peptide.