rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency
| Status: | Terminated |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 5 - Any |
| Updated: | 1/31/2019 |
| Start Date: | December 2007 |
| End Date: | March 2012 |
Recombinant Human Growth Hormone (rhGH) and Recombinant Human Insulin-like Growth Factor-1 rhIGF-1) Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency: A Six-year, Randomized, Multi-center, Open-label, Parallel-group, Active Treatment Controlled, Dose Selection Trial
IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in
response to another hormone called growth hormone. Growth Hormone is produced by a small
gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors
to growth during infancy, childhood, and adolescence.
Children with IGF Deficiency are short and have an imbalance in the levels of growth hormone
and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but
IGF-1 levels do not increase normally in response to growth hormone. As a result, they have a
type of growth hormone insensitivity and an inability to grow normally.
This study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will
help children with IGFD grow taller more quickly than children treated with rhGH alone. The
study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration
(FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH
in children with IGF-1 deficiency (IGFD) is investigational.
response to another hormone called growth hormone. Growth Hormone is produced by a small
gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors
to growth during infancy, childhood, and adolescence.
Children with IGF Deficiency are short and have an imbalance in the levels of growth hormone
and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but
IGF-1 levels do not increase normally in response to growth hormone. As a result, they have a
type of growth hormone insensitivity and an inability to grow normally.
This study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will
help children with IGFD grow taller more quickly than children treated with rhGH alone. The
study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration
(FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH
in children with IGF-1 deficiency (IGFD) is investigational.
Inclusion Criteria:
- Parents or legally authorized representatives must give signed informed consent before
any trial-related activities
- IGF-1 SDS of ≤ -1 for age and gender
- Short stature, as defined by a height SDS of ≤ -2 for age and gender
- Chronological age ≥ 5 years
- Bone age ≤ 11 years in boys and ≤ 9 years in girls
- GH sufficiency, defined as a maximal stimulated GH response of greater than or equal
to 10 ng/mL at Visit 2 (note: upon approval of the Medical Monitor, the result of a
prior GH stimulation test may satisfy this requirement).
- Prepubertal status
- Adequate nutrition as evidenced by a body mass index (BMI) greater than or equal to
the 5th percentile for age and gender
Exclusion Criteria:
- Severe Primary IGFD (defined as height and IGF-1 SDS ≤ 3, and stimulated GH response
greater than or equal to 10 ng/mL)
- Prior or current use of medications with the potential to alter growth patterns
including GH, IGF-1, IGFBP-3, gonadotrophin agonists (e.g., Lupron), aromatase
inhibitors, androgens and estrogens
- Known or suspected allergy to rhGH, rhIGF-1 or a constituent of their formulations
- Current use of medications for attention deficit disorder
- A chronic health condition that requires anti-inflammatory steroids or daily
medication unless approved by the Medical Monitor
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