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

Growth Hormone Deficiency Clinical Trial

Official title:

A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin®

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01243892
• Other study ID #: L4917g
• Secondary ID: ML01311
• Status: Terminated
• Phase: N/A
• First received: November 17, 2010
• Last updated: June 27, 2016
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: June 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 14 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency

Intervention

Device:
• NuSpin
Device for administration of doses of somatropin.
• Nutropin AQ
Device for administration of doses of somatropin.

Genetic:
• Somatropin
Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants whose annualized height velocity changed by 1.5 centimeters (cm) over two years of rhGH therapy		Baseline up to Year 2	No
Secondary	Percentage of Participants whose height velocity changed by 1 cm within first year of rhGH therapy		Baseline up to Year 1	No
Secondary	Percentage of Participants whose height velocity changed by 0.5 cm within second year of rhGH therapy		Year 1 up to Year 2	No