IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric... | NCT01676090

Studies
IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric Spanish Population

NCT01676090

Sponsor

Ipsen

Status

Terminated

Last Update Posted

Jan 11, 2019Actual

Enrollment

304Actual

Phase

Not provided

Conditions

IGF-1 Deficiency

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Participant enrolment was lower than expected

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Aug 22, 2012

First Submission Date that Met QC Criteria

Aug 29, 2012

First Posted Date

Aug 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2019

Last Update Posted Date

Jan 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex and pubertal stage of a healthy paediatric Spanish population.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

304Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IGF-1 levels according to age, sex and pubertal stage in healthy paediatric volunteers		At the time of participant's single study visit (day 1)

Secondary Outcomes

Measure	Description	Time Frame
IGFBP-3 levels according to age, sex and pubertal stage in healthy paediatric volunteers		At the time of participant's single study visit (day 1)
ALS levels according to age, sex and pubertal stage in healthy paediatric volunteers		At the time of participant's single study visit (day 1)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children of either sex of Caucasian parents
Age: newborns up to and including 18 years of age
Length/height, weight and body mass index (BMI) within the mean +/- 2SD (Standard Deviation) and in accordance with the growth charts of the 2010 Spanish cross-sectional growth study (Carrascosa Lezcano et al 2010)
Signed consent by at least one parent or legal guardian (if subject is ≤18 years) and by subject if ≥12 years

Exclusion Criteria:

Early or advanced puberty (pubertal signs: between 8 and 9 years old in girls, and between 9 and 10 years old in boys), or delayed puberty (no puberty onset in ≥ 13 year-old girls, and in ≥ 14 year-old boys)
Chronic diseases including, but not limited to, endocrinologic diseases, chromosomal diseases, chronic diseases of renal, hepatic and/or cardiac aetiology, and tumour processes
An acute disease during the last two weeks prior to recruitment
Any clinically significant out-of-range lab value
Healthy paediatric volunteers who are under medical treatment (contraception permitted)
A family history of short stature (either parent < P3)
Children born small for gestational age (birth weight, length, or head circumference < P10)
Adopted children or conceived through in vitro fertilization ( IVF )
Subjects who are unwilling or unable in the opinion of the investigator or sponsor to undergo all the study procedures

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Healthy paediatric Spanish population

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Fundación Sant Joan de Deu		Barcelona			Spain
Hospital Universitari Vall d´Hebron