Status:
TERMINATED
A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device
Lead Sponsor:
Genentech, Inc.
Conditions:
Growth Hormone Deficiency
Eligibility:
All Genders
2-14 years
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 sho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01243892
Start Date
November 1 2010
End Date
August 1 2011
Last Update
December 1 2016
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States, 35233
2
Scottsdale, Arizona, United States, 85258
3
Sacramento, California, United States, 95819
4
San Diego, California, United States, 92123