Growth Hormone Deficiency Clinical Trial
Official title:
A Phase IV, Multicenter, Open-Label Study of the Immunogenicity of Nutropin AQ® V1.1 [Somatropin (rDNA Origin) Injection] Administered Daily to Naïve Growth Hormone-Deficient Children (iSTUDY)
Verified date | December 2018 |
Source | Genentech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | November 8, 2017 |
Est. primary completion date | November 8, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 14 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Emory Children's Center | Atlanta | Georgia |
United States | Barry J Reiner, MD, LLC | Baltimore | Maryland |
United States | Boston Childrens Hospital | Boston | Massachusetts |
United States | Rocky Mountain Pediatric Endocrinology, PC | Centennial | Colorado |
United States | UNC General Pediatrics Clinic | Chapel Hill | North Carolina |
United States | Medical University of South Carolina; MUSC Pediatric Endocrinology | Charleston | South Carolina |
United States | Endocrine Associates of Dallas | Dallas | Texas |
United States | Cook Children's Hospital | Fort Worth | Texas |
United States | Pediatric Endocrine Associates | Greenwood Village | Colorado |
United States | Hackensack University Medical Center PARTNER | Hackensack | New Jersey |
United States | Milton S Hershey Ped Sub Spclt | Hershey | Pennsylvania |
United States | Nemours Children's Clinic - of the Nemours Foundation | Jacksonville | Florida |
United States | Children's Mercy Hospitals & Clinics; Pulmonology | Kansas City | Missouri |
United States | Arkansas Children's Hospital Research Institute | Little Rock | Arkansas |
United States | University of Louisville | Louisville | Kentucky |
United States | Miami Children's Hospital | Miami | Florida |
United States | University of Minnesota Childrens' Hospital | Minneapolis | Minnesota |
United States | New York Presbyterian Hospital | New York | New York |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Children'S Hospital of Orange County | Orange | California |
United States | Nemours Childrens Clinic | Orlando | Florida |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Center of Excellence in Diabetes & Endocrinology | Sacramento | California |
United States | Children's Healthcare d.b.a Children's Hospitals and Clinics of Minnesota | Saint Paul | Minnesota |
United States | San Diego Medical Group; Pediatric Endocrinology | San Diego | California |
United States | Baystate Endocrinology and Diabetes; Baystate Children's Specialty Center, Pediatric Endocrinology | Springfield | Massachusetts |
United States | MultiCare Health System Institute for Research and Innovation | Tacoma | Washington |
United States | MultiCare Institute for Research and Innovation | Tacoma | Washington |
United States | The Pediatric Endocrine Office of Larry C. Deeb | Tallahassee | Florida |
United States | Pediatric Endrocine Assoc | Tampa | Florida |
United States | USF Diabetes Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Genentech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1 | Participants who were tested positive to anti-GH antibody after initiation of study treatment. | Baseline up to 1 year | |
Secondary | Percentage of Participants Who Exhibit Functional Growth Attenuation | Growth attenuation is defined as initial growth response greater than pretreatment velocity followed by reduction in growth response to below the pretreatment velocity in the subsequent 6- to 12-month treatment period or reaching = 2 cm per year. | Baseline up to 1 year | |
Secondary | Percentage of Participants With Neutralizing Antibodies | Among participants who developed positive anti-GH antibody post-baseline, participants who were tested positive to neutralizing anti-GH antibody during study participation. | Baseline up to 1 year | |
Secondary | Annualized Growth Velocity at Months 6 and 12 (Change From Baseline) | Annualized growth velocity is defined as (height - baseline height) / (date of height assessment - date of baseline)*365.25. Results are presented according to anti-GH antibody status (positive included all participants that were anti-GH antibody positive at least once post-baseline visit and anti-GH antibody negative population included all participants that were anti-GH antibody negative at all post-baseline visits). | Months 6, 12 | |
Secondary | Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline) | Height Standard Deviation Score (SDS) allows for the comparison of a participants height to that of others in the same age group. Therefore, the average height for that age group will have the SDS of 0. In this study, the starting Height SDS score was = -1.5 (= 5th percentile). Results are presented according to anti-GH antibody status (positive included all participants that were anti-GH antibody positive at least once post-baseline visit and anti-GH antibody negative population included all participants that were anti-GH antibody negative at all post-baseline visits. | Months 6, 12 | |
Secondary | Percentage of Participants With Adverse Events | Among participants who received at least one dose of study drug, those who reported at least one adverse event during study participation. | Baseline up to 1 year |
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