Status:
COMPLETED
Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD
Lead Sponsor:
Pfizer
Conditions:
Growth Hormone Deficiency
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief Summary
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 (...
Detailed Description
Subjects will be randomized to one of two sequences, either 12 weeks of continued treatment with daily Genotropin followed by 12 weeks of treatment with weekly somatrogon, or 12 weeks of treatment wit...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion Criteria
- 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).
Exclusion
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2020
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT03831880
Start Date
February 7 2019
End Date
August 28 2020
Last Update
October 14 2021
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
Center of Excellence in Diabetes and Endocrinology
Sacramento, California, United States, 95821
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Rocky Mountain Pediatric Endocrinology
Centennial, Colorado, United States, 80112
4
Pediatric Endocrine Associates, PC
Greenwood Village, Colorado, United States, 80111