Clareo Health | A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
3–14
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
