Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD

Completed · Phase 3

Conditions studied: Growth Hormone Deficiency

In brief

This is an open label randomized 24 week crossover trial assessing the treatment burden of a weekly growth hormone injection regimen (somatrogon) compared to a daily growth hormone injection regimen (Genotropin). Approximately 90 children with growth hormone deficiency who have been stable on treatment with daily Genotropin will be enrolled.

Key facts

Study ID: NCT03831880
Run by: Pfizer
People needed: 87
Starts: 2019-02-07
Expected to finish: 2020-08-28
Last updated by the study team: 2021-10-14

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Children aged 3 years old and <18 years with either isolated GHD, or GH insufficiency.
Currently on treatment with either Genotropin Pen®, Genotropin GoQuick Pen®, HumatroPen® (United States of America [USA] only), or Omnitrope® Pen (USA only) ≥3 months and have been compliant on a stable dose (±10%) for at least 3 months prior to screening.
IGF I SDS < 2.
Subjects on hormonal replacement therapy for other hypothalamic pituitary axis (HPA) hormonal deficiencies and/or diabetes insipidus must be on an optimized and stable treatment regimen, as determined by the Investigator, for at least 3 months prior to screening.

You may not qualify if…

History of leukemia, lymphoma, sarcoma or any other cancer.
History of radiation therapy or chemotherapy.
Children with psychosocial dwarfism.
Children born small for gestational age (SGA) - birth weight and/or birth length < 2 SDS for gestational age.
Other causes of short stature such as uncontrolled primary hypothyroidism and rickets.
Chromosomal abnormalities including Turner's syndrome, Laron syndrome, Noonan syndrome, Prader Willi syndrome, Russell Silver syndrome, short stature homeobox (SHOX) mutations/deletions or skeletal dysplasias.
Treatment with regularly scheduled daily or weekly injectable medications other than Genotropin® Pen, Genotropin GoQuick®, HumatroPen® (USA only), or Omnitrope® Pen (USA only).
Diabetes Mellitus.
Current treatment with Genotropin MiniQuick.
History of any exposure to a long acting hGH preparation.
Known or suspected human immunodeficiency virus (HIV) positive patient, or patient with advanced diseases such as acquired immunodeficiency syndrome (AIDS) or tuberculosis.
Drug, substance, or alcohol abuse.
Known hypersensitivity to the components of the medication.
Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.
Patient and/or the parent/legal guardian are likely to be non-compliant with respect to study conduct.
Subject and/or the parent/legal guardian are unable to understand written and/or verbal instructions on the proper use of growth hormone injection devices.
Children with closed epiphyses (this determination can be based on available existing clinical data).

Where it is running

Center of Excellence in Diabetes and Endocrinology — Sacramento, California, United States
Children's Hospital Colorado — Aurora, Colorado, United States
Rocky Mountain Pediatric Endocrinology — Centennial, Colorado, United States
Pediatric Endocrine Associates, PC — Greenwood Village, Colorado, United States
Nemours Children's Health System — Jacksonville, Florida, United States
Nemours Children's Specialty Care — Jacksonville, Florida, United States
Nemours Biomedical Research — Orlando, Florida, United States
Nemours Children's Hospital — Orlando, Florida, United States
Nemours Children's Clinic — Pensacola, Florida, United States
Shriners Hospitals for Children — Tampa, Florida, United States
Emory Children's Center — Atlanta, Georgia, United States
IU Health Pharmacy — Indianapolis, Indiana, United States
Riley Hospital for Children — Indianapolis, Indiana, United States
Children's Mercy Hospital and Clinics — Kansas City, Missouri, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
MultiCare Health System - Mary Bridge Children's Health Center — Tacoma, Washington, United States
MultiCare Institute for Research & Innovation — Tacoma, Washington, United States
First Pediatric Clinic UMHAT "St. Marina" EAD — Varna, Bulgaria
Fakultni nemocnice Brno, Pediatricka Klinika — Brno, Czechia
Nemocnicni lekarna FN Brno — Brno, Czechia
Fakultni nemocnice v Motole, Pediatricka klinika 2.LF UK a FN Motol — Prague, Czechia
Nemocnicni lekarna FN Motol — Prague, Czechia
Nemocnicna Lekaren Nudch — Bratislava, Slovakia
Národný ústav detských chorôb, Detská klinika — Bratislava, Slovakia

Full record on ClinicalTrials.gov

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