Study Stopped
The study was closed due to the slow enrollment rate.
A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device
A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin®
2 other identifiers
observational
18
1 country
14
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2010
Shorter than P25 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 17, 2010
CompletedFirst Posted
Study publicly available on registry
November 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
December 1, 2016
CompletedDecember 1, 2016
October 1, 2016
9 months
November 17, 2010
October 7, 2016
October 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment
The annualized height velocity (cm per year \[cm/yr\]) over 2 years was calculated as: \[(height in cm at t24 minus (-) height in cm at t0) divided by (date at t24 - date at t0)\] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit.
Baseline up to Month 24 (Year 2)
Secondary Outcomes (2)
Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment
Baseline up to Month 12 (Year 1)
Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy
Month 12 to Month 24 (Year 1 to Year 2)
Study Arms (2)
Cohort 1: IGHD participants
Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid \[DNA\] origin) (recombinant human growth hormone \[rhGH\]) using the NuSpin device, will be observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen will be as per treating physician's discretion, the study protocol does not enforce or specify any treatment regimen.
Cohort 2: ISS participants
Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, will be observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen will be as per treating physician's discretion, the study protocol does not enforce or specify any treatment regimen.
Interventions
Device for administration of doses of somatropin.
Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.
Eligibility Criteria
Somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (14)
Unknown Facility
Birmingham, Alabama, 35233, United States
Unknown Facility
Scottsdale, Arizona, 85258, United States
Unknown Facility
Sacramento, California, 95819, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Greenwood Village, Colorado, 80111, United States
Unknown Facility
Palm Bay, Florida, 32905, United States
Unknown Facility
Pembrook Pines, Florida, 33028, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Wheaton, Illinois, 60187, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Mount Kisco, New York, 10549, United States
Unknown Facility
New Rochelle, New York, 10801, United States
Unknown Facility
Columbus, Ohio, 43235, United States
Unknown Facility
Knoxville, Tennessee, 37916, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated prematurely due to slow enrollment.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
D. Aaron Davis, M.D.
Genentech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2010
First Posted
November 19, 2010
Study Start
November 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
December 1, 2016
Results First Posted
December 1, 2016
Record last verified: 2016-10