Phase 3
Completed N=251
Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq
Turner syndrome · Renal Insufficiency, Chronic · Pituitary Diseases · Dwarfism
Source: ClinicalTrials.gov NCT00234533 ↗
Enrolled (actual)
251
Serious AEs
2.4%
Results posted
Aug 2018
Primary outcomePrimary: Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples — 223.54; 212.97; 238.02; 226.90 nanograms/milliliter (ng/mL)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq treated children, using newly developed capillary blood spot IGF-1 measurement technology.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples |
223.54; 212.97; 238.02; 226.90; 241.58; 235.47 | — |
| SECONDARY Assessment of IGF-I Levels: Categorised by Weekly Timing (Weeks 21-23) and Daily Timing (Morning and Evening) |
218.3; 232.4; 238.5; 225.1; 234.4 | — |
| SECONDARY Assessment of IGF-I Levels: Categorised by Sex and Prepubertal Status |
234.4; 172.1; 238.9; 168.4 | — |
| SECONDARY Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Disease Condition and Location |
0.058; 0.000; 0.014; -0.070; -0.013; -0.059 | — |
| SECONDARY Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Time of Year, Calculated Age at Enrolment and Disease Condition |
0.118; 0.028; 0.029; 0.000; -0.007; 0.051 | — |
| SECONDARY Change From Baseline at Week 24 in the IGF-I Levels as Measured by Capillary Blood Spot Method and Serum IGF-I Assay |
123.49; 215.41 | — |
| SECONDARY Change From Baseline at Week 12 and Week 24 in Insulin-Like Growth Factor Binding Protein 3 (IGFBP3) Measurements |
1112.4; 1285.2 | — |
| SECONDARY Change From Baseline at Week 24 in the Auxological Parameter Height |
4.73 | — |
| SECONDARY Change From Baseline at Week 24 in the Auxological Parameter Calculated Height SDS |
0.45 | — |
| SECONDARY Change From Baseline at Week 24 in the Auxological Parameter Weight |
2.01 | — |
| SECONDARY Change From Baseline at Week 24 in the Auxological Parameter Calculated Weight SDS |
0.20 | — |
| SECONDARY Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity |
5.20 | — |
| SECONDARY Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity SDS |
5.10 | — |
| SECONDARY Percentage of Patients Rating the Overall Handling of the Administration Device, NutropinAq Pen, to Assess the Acceptability and Tolerance of NutropinAq and Its Pen |
39.8; 52.5; 3.3; 0; 0.4; 4.1 | — |
| SECONDARY Posology of NutropinAq at Baseline (Visit 1) Summarised as Mean Dose |
0.0382 | — |
| SECONDARY Extent of Exposure to NutropinAq Throughout the Study |
159.7 | — |
Eligibility Criteria
Inclusion Criteria
- Children under 18 with growth failure associated with inadequate growth hormone secretion, or Turner syndrome or chronic renal insufficiency.
Exclusion Criteria
- Children with closed epiphyses
- Children with active neoplasm
- Children with acute critical illness
Data sourced from ClinicalTrials.gov (NCT00234533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.