Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02311894
Other study ID # ML29543
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 31, 2015
Est. completion date November 8, 2017

Study information

Verified date December 2018
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT02243852 - Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21) N/A
Completed NCT01440686 - Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers Phase 1
Completed NCT00990340 - Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method Phase 4
Completed NCT00235599 - The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children. N/A
Completed NCT00149708 - Consequence of Lifetime Isolated Growth Hormone Deficiency N/A
Completed NCT00459940 - The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients N/A
Completed NCT01157793 - A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood Phase 4
Completed NCT00004365 - Study of Pituitary Size and Function in Familial Dwarfism of Sindh N/A
Recruiting NCT00227253 - Chromosome 18 Clinical Research Center
Recruiting NCT04121780 - Growth Hormone Replacement Therapy for Retried Professional Football Players Phase 2
Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease
Completed NCT01090778 - Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I) Phase 2
Completed NCT00965484 - Genotropin Study Assessing Use of Injection Pen Phase 3
Completed NCT01062529 - Peripheral Metabolic Effects of Somatostatin N/A
Completed NCT00616278 - National Cooperative Growth Study in CKD N/A
Completed NCT02693522 - Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency Phase 3
Recruiting NCT02908958 - Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency Phase 4
Terminated NCT01243892 - A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device N/A
Withdrawn NCT00638287 - Inter-Assay Growth Hormone and IGF-I Variability N/A
Completed NCT00957671 - Anterior Pituitary Hormone Replacement in Traumatic Brain Injury Phase 4