A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device

Stopped early

Conditions studied: Growth Hormone Deficiency

In brief

This is a Phase IV, open label, case-controlled, observational study to evaluate the age-adjusted cumulative height velocity in pre-pubertal isolated growth hormone deficient (IGHD) and idiopathic short stature (ISS) participants receiving daily doses of somatropin (recombinant human growth hormone \[rhGH\]; Nutropin) using NuSpin device compared to historical controls from the national cooperative growth study (NCGS).

Key facts

Study ID

NCT01243892

Run by

Genentech, Inc.

People needed

18

Starts

2010-11-01

Expected to finish

2011-08-01

Last updated by the study team

2016-12-01

Who can join

Age: 2 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Bone age less than or equal to (</=) 8 years (females) or </= 10 years (males) as determined by x-ray of the left hand and wrist obtained within six months before enrollment
• Prepubertal males and females by physical exam
• Naive to rhGH therapy
• Diagnosis of IGHD or ISS by standard pharmacologic testing and no other discernable etiology for short stature
• Height standard deviation score (Ht SDS) </= -1.5 (</= 5th percentile) for IGHD participants; Ht SDS </= -2.25 (</= 1.2 percentile) for ISS participants

You may not qualify if…

• Short stature etiologies other than IGHD or ISS
• Participants receiving chronic corticosteroid therapy (greater than [>] 3 months) for other medical conditions
• Participants with active malignancy or any other condition that the investigator believes would pose a significant hazard to the participant if rhGH were initiated
• Females with turner syndrome
• Any previous rhGH treatment
• Participation in another simultaneous medical investigation or trial
• Pediatric participants with closed epiphyses
• Participants prescribed rhGH doses outside the variance of NCGS control participant dosing

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Greenwood Village, Colorado, United States
• Study site — Palm Bay, Florida, United States
• Study site — Pembrook Pines, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Wheaton, Illinois, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Mount Kisco, New York, United States
• Study site — New Rochelle, New York, United States
• Study site — Columbus, Ohio, United States
• Study site — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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