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

Genentech

Status: Terminated

Conditions: Growth Hormone Deficiency

Treatments: Drug: Somatropin; Device: NuSpin

Study type: Observational

Funder types: Industry

Identifiers

NCT01243892

ML01311 (Other Identifier)

L4917g

Details and patient eligibility

About

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).

Enrollment: 18 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 2 patient groups

Cohort 1: IGHD participants

Description:

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.

Treatment:

Device: NuSpin

Drug: Somatropin

Cohort 2: ISS participants

Description:

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.

Treatment:

Device: NuSpin

Drug: Somatropin