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NCT Number: NCT02311894

A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency

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.

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arkansas Children's Hospital Research Institute, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin

Drug

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 names: Nutropin AQ v1.1

Primary outcomes

  1. Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1

    Time frame: Baseline up to 1 year

    Participants who were tested positive to anti-GH antibody after initiation of study treatment.

Secondary outcomes

  1. Percentage of Participants Who Exhibit Functional Growth Attenuation

    Time frame: Baseline up to 1 year

    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.

  2. Percentage of Participants With Neutralizing Antibodies

    Time frame: Baseline up to 1 year

    Among participants who developed positive anti-GH antibody post-baseline, participants who were tested positive to neutralizing anti-GH antibody during study participation.

  3. Annualized Growth Velocity at Months 6 and 12 (Change From Baseline)

    Time frame: Months 6, 12

    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).

  4. Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline)

    Time frame: Months 6, 12

    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.

  5. Percentage of Participants With Adverse Events

    Time frame: Baseline up to 1 year

    Among participants who received at least one dose of study drug, those who reported at least one adverse event during study participation.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2014
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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