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Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq (OPTIMA)

Primary Purpose

Turner Syndrome, Renal Insufficiency, Chronic, Pituitary Diseases

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Somatropin (rDNA origin)
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Turner Syndrome focused on measuring growth, child development, growth hormone, inadequate growth hormone secretion, growth failure

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dienst Kindergeneeskunde
  • Dienst Kindergeneeskunde
  • Klinika Deti a Dorostu
  • Aalborg Sygehus Nord, Borneafdelingen
  • Sygeh. i Ringkjobing Amt, Borneafdeling
  • Helsinki University Central Hospital
  • CHU - Hôtel Dieu
  • Cabinet Médical
  • CHU Grenoble
  • Centre Hospitalier General
  • CHU Timone Enfants
  • CHU de Montpellier
  • Hôpital Archet 2
  • Hôpital Saint-Vincent de Paul
  • Groupe Hospitalier de Necker
  • Hôpital Charles Nicolle
  • CHU Hautepierre
  • Centre Hospitalier de Bigorre
  • Cabinet Médical
  • Hôpital des Enfants
  • Centre Pédiatrique Gatien de Clocheville
  • Universitätsklinikum Leipzig AöR
  • Universitätsklinikum Tübingen
  • General State Hospital of Nikaia
  • PA Kyriakou Children's Hospital
  • Azienda Policlinico - Università di Catania
  • Ospedale Policlinico
  • Clinica Pediatrica II
  • Il Università degli Studi di Napoli
  • Clinica Pediatrica, Universita Federico II di Napoli
  • Clinica Pediatrica
  • Clinica Pediatrica
  • Institutul de Endocrinologie C.I. Parhon
  • Endocrinology Research Centre RAMS, Institute of Pediatric Endocrinology
  • Tushino Pediatric Hospital, RMAPE Department of Endocrinology for Childhood and Adolescent Age
  • Il Detska Klinika
  • Hospital de Nens de Barcelona
  • Hospital General Universitario
  • Hospital Gregorio Marañón
  • Hospital Parc Taulí
  • Hospital Clínico Universitario
  • Scientific-Research Institute of Endocrinology, Academy of Medical Science of Ukraine
  • Ukrainian Scientific practical Centre of Endocrine surgery, Endocrine Organs and Tissues Transplantation
  • St George's Hospital
  • University Hospital Wales

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NutropinAq 10 mg/2 mL (30 IU)

Arm Description

Patients received daily subcutaneous (s.c.) injections of NutropinAq 10 milligrams (mg)/2 milliliters (mL) for 6 months. The therapeutic daily doses administered were as follows: GHD patients: 0.025 - 0.035 mg/ kilogram (kg) bodyweight TS patients: up to 0.05 mg/kg bodyweight CRI patients: up to 0.05 mg/kg bodyweight Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23. The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.

Outcomes

Primary Outcome Measures

Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples
Fingertip capillary blood was collected using filter paper cards for the assay of capillary blood spot IGF-I in line with the monitoring recommendations of the Lawson Wilkins Paediatric Endocrine Society (LWPES) for treatment with recombinant GH therapy in children. Capillary IGF-I assays were performed by the patient at home one day per week during Weeks 21, 22 and 23 only (same week day). The samples were scheduled in the evening prior to the injection of NutropinAq and between 7:00 and 9:00 the following morning. An extended window from 6:00 to 12:00 was allowed for defining protocol deviations. The number of capillary blood spot IGF-I measurements and the optimal timing of samples to assess the IGF-I status of NutropinAq treated patients was assessed. IGF-I measurements for the morning and evening sampling are presented.

Secondary Outcome Measures

Assessment of IGF-I Levels: Categorised by Weekly Timing (Weeks 21-23) and Daily Timing (Morning and Evening)
The influence of daily and weekly timing on the IGF-I value as measured using the capillary blood spot method was analysed. A 3-way analyses of variance (ANOVA) was performed with patient, day and daily timing as factors after appropriate transformation to obtain normally distributed parameters. The interaction day*time was tested and kept in the model only if p-value<0.1. Parameter estimates from the statistical model are presented as least squares means for the categories of daily timing (Morning and Evening) and weekly timing (Week 21, Week 22 and Week 23). The values reported for Week 21, 22, and 23 represent the average IGF-I levels from the morning and evening samples at each week. The values reported for Evening represent the Evening IGF-I levels averaged across Weeks 21, 22, and 23, and similarly for the Morning values.
Assessment of IGF-I Levels: Categorised by Sex and Prepubertal Status
The influence of sex and prepubertal status on the IGF-I value as measured using the capillary blood spot method was analysed. Parameter estimates from the statistical model are presented as least squares means for the categories of sex (male and female) and prepubertal status (pubertal and prepubertal). The values reported represent average IGF-I levels as determined from the 6 measurements taken (i.e. morning and evening samples at Weeks 21, 22 and 23).
Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Disease Condition and Location
A multivariate linear regression analysis of factors on within-subject coefficient of variation (WCV) using a stepwise forward-backward elimination was used to determine the effect of individual factors on IGF-I values as measured using the capillary blood spot method (p=0.15 for a variable to enter and remain in the model). The WCV was computed from the series of 6 measurements (2 samplings in each of Weeks 21, 22 and 23). The influence of disease condition and country clusters on the IGF-I value were assessed. Country clusters: cluster 1: France; cluster 2: Spain, Greece, Romania and Italy; cluster 3: UK, Belgium, Czech Republic, Denmark, Germany, Slovakia, Austria and Finland ; cluster 4: Russia ; cluster 5: Ukraine. Parameter estimates from the statistical model presented as least squares means for categories of disease condition (GHD and TS) and location (Clusters 1, 2, 3, 4 and 5) are presented.
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
A multivariate linear regression analysis of factors on WCV using a stepwise forward-backward elimination was used to determine the effect of individual factors on IGF-I values as measured using the capillary blood spot method (p=0.15 for a variable to enter and remain in the model). The WCV was computed from the series of 6 measurements (2 samplings in each of Weeks 21, 22 and 23). The influence of the time of the year (1st, 2nd, 3rd and 4th quarters), calculated age at enrolment and disease condition on the IGF-I value were assessed. Parameter estimates from the statistical model are presented as least squares means for the categories of time of the year (1st, 2nd, 3rd and 4th quarters), calculated age at enrolment and disease condition (GHD and TS).
Change From Baseline at Week 24 in the IGF-I Levels as Measured by Capillary Blood Spot Method and Serum IGF-I Assay
3 simultaneous IGF-I measurements were taken at Weeks 0 (baseline), 12 and 24 by serum and capillary assay to determine the precision profile of the capillary blood spot method versus the serum IGF-I assay. Change from baseline at Week 24 in the IGF-I measurements by capillary blood spot method and serum assay are presented.
Change From Baseline at Week 12 and Week 24 in Insulin-Like Growth Factor Binding Protein 3 (IGFBP3) Measurements
The LWPES recommends that treatment for any indication with recombinant GH therapy in children be accompanied by regular monitoring of IGF-I and IGFBP3 concentrations. IGFBP3 binds circulating IGF-I and serum samples were taken at Visit 1 (Week 0), Visit 2 (Week 12) and Visit 3 (Week 24) in order to measure IGFBP3. Change from baseline (Visit 1) at Visits 2 and 3 in IGFBP3 is presented.
Change From Baseline at Week 24 in the Auxological Parameter Height
The auxological parameter, height, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). Change from baseline in measured height at Visit 3 (Week 24) for the overall ITT population is presented.
Change From Baseline at Week 24 in the Auxological Parameter Calculated Height SDS
The auxological parameter, height, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Height SDS = (height - reference mean height (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in growth, therefore, a favorable outcome. Change from baseline in the calculated height SDS at Visit 3 (Week 24) for the overall ITT population is presented.
Change From Baseline at Week 24 in the Auxological Parameter Weight
The auxological parameter, weight, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). Change from baseline in measured weight at Visit 3 (Week 24) for the overall ITT population is presented.
Change From Baseline at Week 24 in the Auxological Parameter Calculated Weight SDS
The auxological parameter, weight, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Weight SDS = (weight - reference mean weight (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in weight, therefore, a favorable outcome. Change from baseline in the calculated weight SDS at Visit 3 (Week 24) for the overall ITT population is presented.
Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity
The auxological parameter, annualised growth velocity, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). Change from baseline in the measured annualised growth velocity at Visit 3 (Week 24) for the overall ITT population is presented.
Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity SDS
The auxological parameter, annualised growth velocity, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Annualised GV SDS = (annualised GV - reference mean annualised GV (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in growth velocity, therefore, a favorable outcome. Change from baseline in the annualised growth velocity SDS at Visit 3 (Week 24) for the overall ITT population is presented.
Percentage of Patients Rating the Overall Handling of the Administration Device, NutropinAq Pen, to Assess the Acceptability and Tolerance of NutropinAq and Its Pen
The acceptability was evaluated by a questionnaire at Month 5. The users (parents and/or child) of NutropinAq pen and compliance aid booklet were asked to describe and rate the pen, cartridge, compliance aid booklet and their ease of use. The percentage of patients responding to each category for the assessment of the overall handling of the NutropinAq pen are presented. The categories are: Very easy, Easy, Moderately difficult, Difficult, Very difficult and Missing.
Posology of NutropinAq at Baseline (Visit 1) Summarised as Mean Dose
It was intended that the posology (mg/kg/day) of NutropinAq would remain constant throughout the study. The mean posology adopted at Visit 1 is presented.
Extent of Exposure to NutropinAq Throughout the Study
The extent of treatment exposure throughout the study is presented as the mean number of daily injections performed.

Full Information

First Posted
October 5, 2005
Last Updated
November 21, 2019
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00234533
Brief Title
Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq
Acronym
OPTIMA
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Turner Syndrome, Renal Insufficiency, Chronic, Pituitary Diseases, Dwarfism
Keywords
growth, child development, growth hormone, inadequate growth hormone secretion, growth failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NutropinAq 10 mg/2 mL (30 IU)
Arm Type
Experimental
Arm Description
Patients received daily subcutaneous (s.c.) injections of NutropinAq 10 milligrams (mg)/2 milliliters (mL) for 6 months. The therapeutic daily doses administered were as follows: GHD patients: 0.025 - 0.035 mg/ kilogram (kg) bodyweight TS patients: up to 0.05 mg/kg bodyweight CRI patients: up to 0.05 mg/kg bodyweight Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23. The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
Intervention Type
Drug
Intervention Name(s)
Somatropin (rDNA origin)
Intervention Description
Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months.
Primary Outcome Measure Information:
Title
Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples
Description
Fingertip capillary blood was collected using filter paper cards for the assay of capillary blood spot IGF-I in line with the monitoring recommendations of the Lawson Wilkins Paediatric Endocrine Society (LWPES) for treatment with recombinant GH therapy in children. Capillary IGF-I assays were performed by the patient at home one day per week during Weeks 21, 22 and 23 only (same week day). The samples were scheduled in the evening prior to the injection of NutropinAq and between 7:00 and 9:00 the following morning. An extended window from 6:00 to 12:00 was allowed for defining protocol deviations. The number of capillary blood spot IGF-I measurements and the optimal timing of samples to assess the IGF-I status of NutropinAq treated patients was assessed. IGF-I measurements for the morning and evening sampling are presented.
Time Frame
At Weeks 21, 22 and 23
Secondary Outcome Measure Information:
Title
Assessment of IGF-I Levels: Categorised by Weekly Timing (Weeks 21-23) and Daily Timing (Morning and Evening)
Description
The influence of daily and weekly timing on the IGF-I value as measured using the capillary blood spot method was analysed. A 3-way analyses of variance (ANOVA) was performed with patient, day and daily timing as factors after appropriate transformation to obtain normally distributed parameters. The interaction day*time was tested and kept in the model only if p-value<0.1. Parameter estimates from the statistical model are presented as least squares means for the categories of daily timing (Morning and Evening) and weekly timing (Week 21, Week 22 and Week 23). The values reported for Week 21, 22, and 23 represent the average IGF-I levels from the morning and evening samples at each week. The values reported for Evening represent the Evening IGF-I levels averaged across Weeks 21, 22, and 23, and similarly for the Morning values.
Time Frame
At Weeks 21, 22 and 23
Title
Assessment of IGF-I Levels: Categorised by Sex and Prepubertal Status
Description
The influence of sex and prepubertal status on the IGF-I value as measured using the capillary blood spot method was analysed. Parameter estimates from the statistical model are presented as least squares means for the categories of sex (male and female) and prepubertal status (pubertal and prepubertal). The values reported represent average IGF-I levels as determined from the 6 measurements taken (i.e. morning and evening samples at Weeks 21, 22 and 23).
Time Frame
At Weeks 21, 22 and 23
Title
Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Disease Condition and Location
Description
A multivariate linear regression analysis of factors on within-subject coefficient of variation (WCV) using a stepwise forward-backward elimination was used to determine the effect of individual factors on IGF-I values as measured using the capillary blood spot method (p=0.15 for a variable to enter and remain in the model). The WCV was computed from the series of 6 measurements (2 samplings in each of Weeks 21, 22 and 23). The influence of disease condition and country clusters on the IGF-I value were assessed. Country clusters: cluster 1: France; cluster 2: Spain, Greece, Romania and Italy; cluster 3: UK, Belgium, Czech Republic, Denmark, Germany, Slovakia, Austria and Finland ; cluster 4: Russia ; cluster 5: Ukraine. Parameter estimates from the statistical model presented as least squares means for categories of disease condition (GHD and TS) and location (Clusters 1, 2, 3, 4 and 5) are presented.
Time Frame
Up to Week 24
Title
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
Description
A multivariate linear regression analysis of factors on WCV using a stepwise forward-backward elimination was used to determine the effect of individual factors on IGF-I values as measured using the capillary blood spot method (p=0.15 for a variable to enter and remain in the model). The WCV was computed from the series of 6 measurements (2 samplings in each of Weeks 21, 22 and 23). The influence of the time of the year (1st, 2nd, 3rd and 4th quarters), calculated age at enrolment and disease condition on the IGF-I value were assessed. Parameter estimates from the statistical model are presented as least squares means for the categories of time of the year (1st, 2nd, 3rd and 4th quarters), calculated age at enrolment and disease condition (GHD and TS).
Time Frame
Up to Week 24
Title
Change From Baseline at Week 24 in the IGF-I Levels as Measured by Capillary Blood Spot Method and Serum IGF-I Assay
Description
3 simultaneous IGF-I measurements were taken at Weeks 0 (baseline), 12 and 24 by serum and capillary assay to determine the precision profile of the capillary blood spot method versus the serum IGF-I assay. Change from baseline at Week 24 in the IGF-I measurements by capillary blood spot method and serum assay are presented.
Time Frame
Baseline to Week 24
Title
Change From Baseline at Week 12 and Week 24 in Insulin-Like Growth Factor Binding Protein 3 (IGFBP3) Measurements
Description
The LWPES recommends that treatment for any indication with recombinant GH therapy in children be accompanied by regular monitoring of IGF-I and IGFBP3 concentrations. IGFBP3 binds circulating IGF-I and serum samples were taken at Visit 1 (Week 0), Visit 2 (Week 12) and Visit 3 (Week 24) in order to measure IGFBP3. Change from baseline (Visit 1) at Visits 2 and 3 in IGFBP3 is presented.
Time Frame
Baseline to Week 12 and Week 24
Title
Change From Baseline at Week 24 in the Auxological Parameter Height
Description
The auxological parameter, height, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). Change from baseline in measured height at Visit 3 (Week 24) for the overall ITT population is presented.
Time Frame
Baseline to Week 24
Title
Change From Baseline at Week 24 in the Auxological Parameter Calculated Height SDS
Description
The auxological parameter, height, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Height SDS = (height - reference mean height (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in growth, therefore, a favorable outcome. Change from baseline in the calculated height SDS at Visit 3 (Week 24) for the overall ITT population is presented.
Time Frame
Baseline to Week 24
Title
Change From Baseline at Week 24 in the Auxological Parameter Weight
Description
The auxological parameter, weight, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). Change from baseline in measured weight at Visit 3 (Week 24) for the overall ITT population is presented.
Time Frame
Baseline to Week 24
Title
Change From Baseline at Week 24 in the Auxological Parameter Calculated Weight SDS
Description
The auxological parameter, weight, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Weight SDS = (weight - reference mean weight (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in weight, therefore, a favorable outcome. Change from baseline in the calculated weight SDS at Visit 3 (Week 24) for the overall ITT population is presented.
Time Frame
Baseline to Week 24
Title
Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity
Description
The auxological parameter, annualised growth velocity, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). Change from baseline in the measured annualised growth velocity at Visit 3 (Week 24) for the overall ITT population is presented.
Time Frame
Baseline to Week 24
Title
Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity SDS
Description
The auxological parameter, annualised growth velocity, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Annualised GV SDS = (annualised GV - reference mean annualised GV (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in growth velocity, therefore, a favorable outcome. Change from baseline in the annualised growth velocity SDS at Visit 3 (Week 24) for the overall ITT population is presented.
Time Frame
Baseline to Week 24
Title
Percentage of Patients Rating the Overall Handling of the Administration Device, NutropinAq Pen, to Assess the Acceptability and Tolerance of NutropinAq and Its Pen
Description
The acceptability was evaluated by a questionnaire at Month 5. The users (parents and/or child) of NutropinAq pen and compliance aid booklet were asked to describe and rate the pen, cartridge, compliance aid booklet and their ease of use. The percentage of patients responding to each category for the assessment of the overall handling of the NutropinAq pen are presented. The categories are: Very easy, Easy, Moderately difficult, Difficult, Very difficult and Missing.
Time Frame
At Month 5
Title
Posology of NutropinAq at Baseline (Visit 1) Summarised as Mean Dose
Description
It was intended that the posology (mg/kg/day) of NutropinAq would remain constant throughout the study. The mean posology adopted at Visit 1 is presented.
Time Frame
Visit 1 (Baseline)
Title
Extent of Exposure to NutropinAq Throughout the Study
Description
The extent of treatment exposure throughout the study is presented as the mean number of daily injections performed.
Time Frame
Up to Week 24

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Dienst Kindergeneeskunde
City
Brussels
ZIP/Postal Code
B-1090
Country
Belgium
Facility Name
Dienst Kindergeneeskunde
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Klinika Deti a Dorostu
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Aalborg Sygehus Nord, Borneafdelingen
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Sygeh. i Ringkjobing Amt, Borneafdeling
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Facility Name
CHU - Hôtel Dieu
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Cabinet Médical
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier General
City
Le Havre
ZIP/Postal Code
76083
Country
France
Facility Name
CHU Timone Enfants
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Saint-Vincent de Paul
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Groupe Hospitalier de Necker
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHU Hautepierre
City
Strasbourg
ZIP/Postal Code
67100
Country
France
Facility Name
Centre Hospitalier de Bigorre
City
Tarbes
ZIP/Postal Code
65013
Country
France
Facility Name
Cabinet Médical
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Hôpital des Enfants
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Pédiatrique Gatien de Clocheville
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Universitätsklinikum Leipzig AöR
City
Leipzig
ZIP/Postal Code
04317
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
General State Hospital of Nikaia
City
Athens
ZIP/Postal Code
18454
Country
Greece
Facility Name
PA Kyriakou Children's Hospital
City
Athens
Country
Greece
Facility Name
Azienda Policlinico - Università di Catania
City
Catania
ZIP/Postal Code
78-95123
Country
Italy
Facility Name
Ospedale Policlinico
City
Chieti
ZIP/Postal Code
5-66013
Country
Italy
Facility Name
Clinica Pediatrica II
City
Firenze
ZIP/Postal Code
13-50132
Country
Italy
Facility Name
Il Università degli Studi di Napoli
City
Napoli
ZIP/Postal Code
4-80138
Country
Italy
Facility Name
Clinica Pediatrica, Universita Federico II di Napoli
City
Napoli
Country
Italy
Facility Name
Clinica Pediatrica
City
Novara
ZIP/Postal Code
18-28100
Country
Italy
Facility Name
Clinica Pediatrica
City
Parma
ZIP/Postal Code
14-43100
Country
Italy
Facility Name
Institutul de Endocrinologie C.I. Parhon
City
Bucuresti
ZIP/Postal Code
Sector 1
Country
Romania
Facility Name
Endocrinology Research Centre RAMS, Institute of Pediatric Endocrinology
City
Moscow
Country
Russian Federation
Facility Name
Tushino Pediatric Hospital, RMAPE Department of Endocrinology for Childhood and Adolescent Age
City
Moscow
Country
Russian Federation
Facility Name
Il Detska Klinika
City
Bratislava
ZIP/Postal Code
833 40
Country
Slovakia
Facility Name
Hospital de Nens de Barcelona
City
Barcelona
ZIP/Postal Code
08009
Country
Spain
Facility Name
Hospital General Universitario
City
Elche
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Parc Taulí
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Clínico Universitario
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Scientific-Research Institute of Endocrinology, Academy of Medical Science of Ukraine
City
Kiev
Country
Ukraine
Facility Name
Ukrainian Scientific practical Centre of Endocrine surgery, Endocrine Organs and Tissues Transplantation
City
Kiev
Country
Ukraine
Facility Name
St George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
University Hospital Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
14 4XW
Country
United Kingdom

12. IPD Sharing Statement

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Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq

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