A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary
Intervention: Somatropin
Intervention description: Somatropin will be administered as SC injections at a dose of up to 0.043 mg/kg/day. The dose may be adjusted for a change in body weight of at least (plus [+]/minus [-]) 2 kilograms (kg) from baseline at the Month 6 study visit or for a change in insulin-growth factor-1 (IGF-1), as per investigator assessment.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 3 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      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) naïve to
      prior recombinant human growth hormone (rhGH) treatment. The study is designed to
      characterize the immunogenicity profile of somatropin (rDNA origin) injection when
      administered daily subcutaneously for 12 months. The clinical impact of immunogenicity will
      also be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bone age less than equal to (</=) 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 12 months prior to enrollment

          -  Prepubertal (Tanner I) males and females by physical examination

          -  Diagnosis of GHD (stimulated GH less than [<] 10 nanograms per milliliter [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 12 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 participants

        Exclusion Criteria:

          -  Any previous 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 participant 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

          -  Participants receiving oral or inhaled chronic corticosteroid therapy (greater than
             [>] 3 months) for other medical conditions other than central adrenal insufficiency

          -  Participants 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

          -  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 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

          -  Participants with closed epiphyses

          -  Participants with a known hypersensitivity to somatropin, excipients, or diluent