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

This study has been terminated.
(The study was closed due to the slow enrollment rate.)
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01243892
First received: November 17, 2010
Last updated: June 27, 2016
Last verified: June 2016
  Purpose
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).

Condition Intervention
Growth Hormone Deficiency
Device: NuSpin
Device: Nutropin AQ
Genetic: Somatropin

Study Type: Observational
Study Design: Observational Model: Cohort
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, Inc.:

Primary Outcome Measures:
  • Percentage of Participants whose annualized height velocity changed by 1.5 centimeters (cm) over two years of rhGH therapy [ Time Frame: Baseline up to Year 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants whose height velocity changed by 1 cm within first year of rhGH therapy [ Time Frame: Baseline up to Year 1 ] [ Designated as safety issue: No ]
  • Percentage of Participants whose height velocity changed by 0.5 cm within second year of rhGH therapy [ Time Frame: Year 1 up to Year 2 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort 1: IGHD participants
IGHD participants receiving somatropin using the NuSpin device will be observed for at least 2 years.
Device: NuSpin
Device for administration of doses of somatropin.
Genetic: Somatropin
Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.
Other Name: Nutropin; rhGH
Cohort 2: ISS participants
ISS participants receiving somatropin using the NuSpin device will be observed for at least 2 years.
Device: NuSpin
Device for administration of doses of somatropin.
Genetic: Somatropin
Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.
Other Name: Nutropin; rhGH
NCGS control participants
IGHD and ISS participants who received somatropin using Nutropin AQ pen within the past 7 years and have remained pre-pubertal at the completion of at least 2 years of therapy will be observed retrospectively from NCGS database.
Device: Nutropin AQ
Device for administration of doses of somatropin.
Genetic: Somatropin
Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.
Other Name: Nutropin; rhGH

  Eligibility

Ages Eligible for Study:   2 Years to 14 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Somatropin-Naive pre-pubertal participants with growth hormone deficiency or ISS
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
  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, Alabama
Birmingham, Alabama, United States, 35233
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, California
Sacramento, California, United States, 95819
San Diego, California, United States, 92123
United States, Colorado
Greenwood Village, Colorado, United States, 80111
United States, Florida
Palm Bay, Florida, United States, 32905
Pembrook Pines, Florida, United States, 33028
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
Wheaton, Illinois, United States, 60187
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Mount Kisco, New York, United States, 10549
New Rochelle, New York, United States, 10801
United States, Ohio
Columbus, Ohio, United States, 43235
United States, Tennessee
Knoxville, Tennessee, United States, 37916
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: D. Aaron Davis, M.D. Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01243892     History of Changes
Other Study ID Numbers: L4917g  ML01311 
Study First Received: November 17, 2010
Last Updated: June 27, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 21, 2016