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Completed

NCT Number: NCT00125190

Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency

This study is intended to assess the effects of once daily dosing of recombinant human insulin-like growth factor (rhIGF-1) in increasing height velocity.

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Key information

Conditions

Insulin-Like Growth Factor-1 Deficiency Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ipsen

Brisbane, California, 94005, United States

About this study

Growth failure associated with primary IGF-1 deficiency (IGFD). Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in growth hormone (GH) action. In this protocol, primary IGFD is defined as short stature (<-2 standard deviations [SDs] below the mean for age and gender), and abnormal serum IGF-1 (<-2 SDs below the mean for age and gender).

The trial is an open-label, concentration-controlled trial conducted at up to 20 centers throughout the United States.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronological age ≥ 3
  • Chronological age or bone age ≤ 12 for boys and ≤ 11 for girls
  • Prepubertal at Visit 1
  • Height SD score of < -2
  • IGF-1 SD score of < -2

Exclusion criteria

  • Prior treatment with GH, IGF-1, or other growth-influencing medications
  • Growth failure associated with other identifiable causes (e.g., syndromes, chromosomal abnormality)
  • Chronic illness such as diabetes, cystic fibrosis, etc.

Treatment and study plan

rhIGF-1 (mecasermin) for a period of 86 weeks

Drug

Once a day rhIGF-1 injections

Primary outcomes

  1. Height Velocity From Pretreatment (Week 0) to Week 34

    Time frame: Pretreatment to Week 34

    Height was measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. The subject was repositioned between each measurement. Height velocity during an interval of time is defined as the change in height during the time interval divided by the duration of the time interval. Missing Week 34 heights were imputed using the last height SD score carried forward.

  2. Height Velocity From Week 34 to 86

    Time frame: Week 34 to 86

    Height was measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. The subject was repositioned between each measurement. Height velocity during an interval of time is defined as the change in height during the time interval divided by the duration of the time interval. Missing Week 86 heights were imputed using the last height SD score carried forward.

Secondary outcomes

  1. Change in Height SD Score From Pretreatment to Week 34

    Time frame: Pretreatment and Week 34

    Height was measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. The subject was repositioned between each measurement. The SD score is calculated as the subject value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.

  2. Change in Height SD Score From Pretreatment to Week 86

    Time frame: Pretreatment and Week 86

    Height was measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Subjects were repositioned between each measurement. The SD score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.

  3. Change in Bone Age From Pretreatment to Week 86 Minus Change in Chronological Age

    Time frame: Pretreatment to Week 86

    Plain X-rays of the left hand and wrist were exposed for bone age appraisal. The films were sent to a central facility for standardized evaluation.

  4. Percent Change in Serum Concentration of IGFBP-1, IGFBP-2 and IGFBP-3 From Pretreatment to Week 86

    Time frame: Pretreatment and Week 86

    Growth factor panels for measuring IGFBP-1, IGFBP-2 and IGFBP-3 were evaluated from screening and at each study visit up to Week 86. Inter-quartile range (Q1-Q3) is 10th to 90th percentile.

  5. Percent Change in Serum Concentration of ALS From Pretreatment to Week 86

    Time frame: Pretreatment and Week 86

    Growth factor panels for measuring ALS were evaluated from screening and at each study visit up to Week 86. Inter-quartile range (Q1-Q3) is 10th to 90th percentile.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With Primary IGF-1 Deficiency: A Multi-Center, Open Label, Concentration-Controlled Study

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jul 29, 2005
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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