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

Last updated on May 8, 2019

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Study Location
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Deficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Children aged 3 years old and

2. Currently on treatment with either Genotropin Pen or Genotropin GoQuick Pen for at
least 3 months and have been compliant on a stable dose (+/-10%) for at least 3 months
prior to screening.

3. IGF I SDS

4. 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. History of leukemia, lymphoma, sarcoma or any other cancer.

2. History of radiation therapy or chemotherapy.

3. Children with psychosocial dwarfism.

4. Children born small for gestational age (SGA) - birth weight and/or birth length SDS for gestational age.

5. Other causes of short stature such as uncontrolled primary hypothyroidism and rickets.

6. 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.

7. Treatment with injectable medications other than Genotropin Pen or Genotropin GoQuick
(with the exception of intramuscular testosterone and immunizations).

8. Diabetes Mellitus.

9. Current treatment with Genotropin MiniQuick.

10. History of any exposure to a long acting hGH preparation.

11. Known or suspected human immunodeficiency virus (HIV) positive patient, or patient
with advanced diseases such as acquired immunodeficiency syndrome (AIDS) or
tuberculosis.

12. Drug, substance, or alcohol abuse.

13. Known hypersensitivity to the components of the medication.

14. 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.

15. 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.

NCT03831880
Pfizer
Recruiting
Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD

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Pfizer Clinical Trials Contact Center

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[email protected]

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Growth Hormone Deficiency
NCT03831880
All Genders
3+
Years
Multiple Sites

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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