A Study of Growth in Patients Using the Nutropin AQ Nuspin (NuSpin Go)

This study has been terminated.
(The study was closed due to the slow enrollment rate.)
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01243892
First received: November 17, 2010
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

This is a phase IV, multi-center, open label, case-controlled, observational study evaluating prepubertal, rhGH-naive subjects who receive daily doses of rhGH with the NuSpin device.


Condition Phase
Growth Hormone Deficiency
Idiopathic Short Stature
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ Nuspin

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • 1.5 cm change in annualized height velocity [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Height velocity [ Time Frame: First year ] [ Designated as safety issue: No ]
  • Height velocity [ Time Frame: Second year ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: November 2010
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Growth Hormone Deficiency
Idiopathic Short Stature

  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

prepubertal children with growth hormone deficiency or idiopathic short stature

Criteria

Inclusion Criteria

  • Bone age ≤ 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

Exclusion Criteria

  • Short stature etiologies other than IGHD or ISS will be excluded
  • Subjects receiving chronic corticosteroid therapy (>3 months) for other medical conditions
  • Subjects with active malignancy or any other condition that the investigator believes would pose a signficant hazard to the subject if rhGH were initiated
  • Females with Turner Syndrome
  • Any previous rhGH treatment
  • Participation in another simultaneous medical investigation or trial
  • Pediatric subjects with closed epiphyses
  • Subjects prescribed rhGH doses outside the variance of NCGS control subject dosing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243892

Locations
United States, California
Investigational Site
Sacramento, California, United States, 95819
Investigational Site
San Diego, California, United States, 92123
United States, Colorado
Investigational Site
Greenwood Village, Colorado, United States, 80111
United States, Florida
Investigational Site
Melbourne, Florida, United States, 32901
Investigational Site
Pembrook Pines, Florida, United States, 33028
United States, Illinois
Investigational Site
Wheaton, Illinois, United States, 60187
United States, New York
Investigational Site
Mount Kisco, New York, United States, 10549
Investigational Site
New Rochelle, New York, United States, 10801
United States, Ohio
Investigational Site
Columbus, Ohio, United States, 43235
Sponsors and Collaborators
Genentech
Investigators
Study Director: D. Aaron Davis, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01243892     History of Changes
Other Study ID Numbers: L4917g
Study First Received: November 17, 2010
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dwarfism
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014