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

  • STATUS
    Recruiting
  • sponsor
    Genentech, Inc.
Updated on 25 March 2021

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

Description

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.

Details
Condition Growth Hormone Deficiencies/Abnormalities
Clinical Study IdentifierTX140484
SponsorGenentech, Inc.
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

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
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