Clinical Trial Details

Overview

Research Study Summary

A Phase IV, Multicenter, Open-Label Study of the Immunogenicity of Nutropin AQ® V1.1 [Somatropin (rDNA Origin) Injection] Administered Daily to Naive Growth Hormone-Deficient Children

Purpose

This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin) (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naive to prior recombinant human growth hormone (rhGH) treatment. The study is designed to characterize the immunogenicity profile of Nutropin AQ v1.1 when administered as a daily subcutaneous (SC) injection for 12 months. The clinical impact of immunogenicity will also be assessed. The target sample size is 80 patients.

To Learn more

CW ID: 206708
Date Last Changed: March 24, 2015

Clinical Trial Snapshot

Phase
4
Gender
Both Male and Female
Age
3 to 14 Years
Overall Status
Recruiting
Lead Sponsor
Genentech, Inc.
Facility Type
N/A

Eligibility

Inclusion Criteria:

  • Ability of parent or legal guardian to provide written informed consent and, if applicable, pediatric assent and compliance with study assessments for the full duration of the study (1 year)
  • Male or female age > / = 3 years and < / = 14 years
  • Bone age < / = 9 years (females) or < / = 11 years (males) as determined by X-ray of the left hand and wrist using Greulich and Pyle method and obtained within the 6 months prior to enrollment
  • Prepubertal (Tanner I) males and females by physical exam
  • Diagnosis of GHD (stimulated growth hormone [GH] < 10 ng/mL) by two standard pharmacologic tests obtained up to 12 months prior to informed consent/assent
  • Normal thyroid function test within the 12 months prior to informed consent/assent
  • Normal complete blood counts within 6 months prior to informed consent/assent
  • Documentation of prior height and weight measurements, with height standard deviation score (SDS) < / = 5th percentile for idiopathic isolated GHD patients

Exclusion Criteria:

  • Any previous recombinant human GH (rhGH) treatment
  • Short stature etiologies other than GHD
  • Acute critical illness or uncontrolled chronic illness, which in the opinion of the investigator and Medical Monitor, would interfere with participation in this study, interpretation of the data, or pose a risk to patient safety
  • Chronic illnesses such as inflammatory bowel disease, celiac disease, heart disease, and diabetes
  • Bone diseases such as achondroplasia or hypochondroplasia, intracranial tumor, irradiation, and traumatic brain injury
  • Patients receiving oral or inhaled chronic corticosteroid therapy (> 3 months) for other medical conditions other than central adrenal insufficiency
  • Patients who require higher (2 times or greater than maintenance) doses of corticosteroids for more than 5 days in the 6 months prior to enrollment in the study
  • Patients with active malignancy or any other condition that the investigator believes would pose a significant hazard to the patient if rhGH were initiated
  • Females with Turner syndrome regardless of their GH status
  • Prader-Willi syndrome regardless of GH status
  • Born small for gestational age regardless of GH status
  • Presence of scoliosis requiring monitoring
  • Previous participation in another clinical trial or investigation of GH, treatment for growth failure, or treatment with a biologic agent
  • Patients with closed epiphyses
  • Patients with a known hypersensitivity to somatropin, excipients, or diluent

Contact

Emily Eyth
University of South Florida - USF Diabetes Center
13330 USF Laurel Drive
Tampa, FL 33612
Phone: (813)974-2793

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