Clinical trial NCT00234533: Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq
Official title: Phase IIIB, International, Single Group, Open Study to Define an Optimal Monitoring of IGF-1 in Children Treated With NutropinAq, Using a Novel Capillary Blood Collection Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Turner Syndrome
Renal Insufficiency, Chronic
Pituitary Diseases
Dwarfism
Keywords: growth
child development
growth hormone
inadequate growth hormone secretion
growth failure
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-10-07
Enrollment: 251
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples
timeFrame: At Weeks 21, 22 and 23
Secondary outcomes:
measure: Assessment of IGF-I Levels: Categorised by Weekly Timing (Weeks 21-23) and Daily Timing (Morning and Evening)
timeFrame: At Weeks 21, 22 and 23
measure: Assessment of IGF-I Levels: Categorised by Sex and Prepubertal Status
timeFrame: At Weeks 21, 22 and 23
measure: Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Disease Condition and Location
timeFrame: Up to Week 24
measure: 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
timeFrame: Up to Week 24
measure: Change From Baseline at Week 24 in the IGF-I Levels as Measured by Capillary Blood Spot Method and Serum IGF-I Assay
timeFrame: Baseline to Week 24
measure: Change From Baseline at Week 12 and Week 24 in Insulin-Like Growth Factor Binding Protein 3 (IGFBP3) Measurements
timeFrame: Baseline to Week 12 and Week 24
measure: Change From Baseline at Week 24 in the Auxological Parameter Height
timeFrame: Baseline to Week 24
measure: Change From Baseline at Week 24 in the Auxological Parameter Calculated Height SDS
timeFrame: Baseline to Week 24
measure: Change From Baseline at Week 24 in the Auxological Parameter Weight
timeFrame: Baseline to Week 24
measure: Change From Baseline at Week 24 in the Auxological Parameter Calculated Weight SDS
timeFrame: Baseline to Week 24
measure: Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity
timeFrame: Baseline to Week 24
measure: Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity SDS
timeFrame: Baseline to Week 24
measure: Percentage of Patients Rating the Overall Handling of the Administration Device, NutropinAq Pen, to Assess the Acceptability and Tolerance of NutropinAq and Its Pen
timeFrame: At Month 5
measure: Posology of NutropinAq at Baseline (Visit 1) Summarised as Mean Dose
timeFrame: Visit 1 (Baseline)
measure: Extent of Exposure to NutropinAq Throughout the Study
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Dienst Kindergeneeskunde
city: Edegem
country: Belgium
facility: Dienst Kindergeneeskunde
city: Praha
country: Czechia
facility: Klinika Deti a Dorostu
city: Aalborg
country: Denmark
facility: Aalborg Sygehus Nord, Borneafdelingen
city: Herning
country: Denmark
facility: Sygeh. i Ringkjobing Amt, Borneafdeling
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Angers
country: France
facility: CHU - Hôtel Dieu
city: Bordeaux
country: France
facility: Cabinet Médical
city: Grenoble
country: France
facility: CHU Grenoble
city: Le Havre
country: France
facility: Centre Hospitalier General
city: Marseille
country: France
facility: CHU Timone Enfants
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nice
country: France
facility: Hôpital Archet 2
city: Paris
country: France
facility: Hôpital Saint-Vincent de Paul
city: Paris
country: France
facility: Groupe Hospitalier de Necker
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Strasbourg
country: France
facility: CHU Hautepierre
city: Tarbes
country: France
facility: Centre Hospitalier de Bigorre
city: Toulouse
country: France
facility: Cabinet Médical
city: Toulouse
country: France
facility: Hôpital des Enfants
city: Tours
country: France
facility: Centre Pédiatrique Gatien de Clocheville
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Athens
country: Greece
facility: General State Hospital of Nikaia
city: Athens
country: Greece
facility: PA Kyriakou Children's Hospital
city: Catania
country: Italy
facility: Azienda Policlinico - Università di Catania
city: Chieti
country: Italy
facility: Ospedale Policlinico
city: Firenze
country: Italy
facility: Clinica Pediatrica II
city: Napoli
country: Italy
facility: Il Università degli Studi di Napoli
city: Napoli
country: Italy
facility: Clinica Pediatrica, Universita Federico II di Napoli
city: Novara
country: Italy
facility: Clinica Pediatrica
city: Parma
country: Italy
facility: Clinica Pediatrica
city: Bucuresti
country: Romania
facility: Institutul de Endocrinologie C.I. Parhon
city: Moscow
country: Russian Federation
facility: Endocrinology Research Centre RAMS, Institute of Pediatric Endocrinology
city: Moscow
country: Russian Federation
facility: Tushino Pediatric Hospital, RMAPE Department of Endocrinology for Childhood and Adolescent Age
city: Bratislava
country: Slovakia
facility: Il Detska Klinika
city: Barcelona
country: Spain
facility: Hospital de Nens de Barcelona
city: Elche
country: Spain
facility: Hospital General Universitario
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario
city: Kiev
country: Ukraine
facility: Scientific-Research Institute of Endocrinology, Academy of Medical Science of Ukraine
city: Kiev
country: Ukraine
facility: Ukrainian Scientific practical Centre of Endocrine surgery, Endocrine Organs and Tissues Transplantation
city: London
country: United Kingdom
facility: St George's Hospital
state: England
city: Cardiff
country: United Kingdom
facility: University Hospital Wales
state: Wales
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: