Clinical trial NCT01243892: A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device
Official title: A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin®
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Growth Hormone Deficiency
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 18
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment
timeFrame: Baseline up to Month 24 (Year 2)
Secondary outcomes:
measure: Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment
timeFrame: Baseline up to Month 12 (Year 1)
measure: Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy
timeFrame: Month 12 to Month 24 (Year 1 to Year 2)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Greenwood Village
country: United States
state: Colorado
city: Palm Bay
country: United States
state: Florida
city: Pembrook Pines
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Wheaton
country: United States
state: Illinois
city: Minneapolis
country: United States
state: Minnesota
city: Mount Kisco
country: United States
state: New York
city: New Rochelle
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Knoxville
country: United States
state: Tennessee
Study officials:
affiliation: Genentech, Inc.
name: D. Aaron Davis, M.D.
role: STUDY_DIRECTOR
References: