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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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ClinicalTrials.gov Identifier: NCT02311894
Recruitment Status : Completed
First Posted : December 9, 2014
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Drug: Somatropin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 31, 2015
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : November 8, 2017


Arm Intervention/treatment
Experimental: Somatropin
Children will receive daily SC injections of somatropin at a dose of up to 0.043 milligrams per kilogram per day (mg/kg/day) for 1 year.
Drug: Somatropin
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.
Other Name: Nutropin AQ v1.1




Primary Outcome Measures :
  1. Percentage of Participants who Develop anti-GH Antibodies After Treatment with Nutropin AQ v1.1 [ Time Frame: Baseline up to 1 year ]

Secondary Outcome Measures :
  1. Percentage of Participants who Exhibit Functional Growth Attenuation [ Time Frame: Baseline up to 1 year ]
  2. Annualized Growth Velocity at Months 6 and 12 [ Time Frame: Months 6, 12 ]
  3. Percentage of Participants with Neutralizing Antibodies [ Time Frame: Baseline up to 1 year ]
  4. Percentage of Participants with Adverse Events [ Time Frame: Baseline up to 1 year ]


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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311894


  Show 33 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02311894     History of Changes
Other Study ID Numbers: ML29543
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs