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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02311894 |
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Date of registration:
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04/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
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Scientific title:
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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) |
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Date of first enrolment:
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March 31, 2015 |
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Target sample size:
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82 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02311894 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Bone age less than equal to ( 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)
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
Age minimum:
3 Years
Age maximum:
14 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Intervention(s)
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Drug: Somatropin
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Primary Outcome(s)
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Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1
[Time Frame: Baseline up to 1 year]
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Secondary Outcome(s)
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Percentage of Participants Who Exhibit Functional Growth Attenuation
[Time Frame: Baseline up to 1 year]
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Percentage of Participants With Adverse Events
[Time Frame: Baseline up to 1 year]
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Annualized Growth Velocity at Months 6 and 12 (Change From Baseline)
[Time Frame: Months 6, 12]
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Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline)
[Time Frame: Months 6, 12]
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Percentage of Participants With Neutralizing Antibodies
[Time Frame: Baseline up to 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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