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

Last updated on November 13, 2019

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Study Location
Fakultni nemocnice v Motole, Pediatricka klinika 2.LF UK a FN Motol
Praha 5, , 150 06 Czechia
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.
Show details

1. Children aged 3 years old and

2. 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.

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.
Show details

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 regularly scheduled daily or weekly injectable medications other than
Genotropin® Pen, Genotropin GoQuick®, HumatroPen® (USA only), or Omnitrope® Pen (USA
only).

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.

16. 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.

17. Participation in other studies involving investigational drug(s) within 30 days prior
to study entry and/or during study participation.

18. Patient and/or the parent/legal guardian are likely to be non-compliant with respect
to study conduct.

19. 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.

20. Children with closed epiphyses (this determination can be based on available existing
clinical data).

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

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Descriptive Information
Brief Title  ICMJE Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD
Official Title  ICMJE A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY
Brief SummaryThis 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.
Detailed DescriptionSubjects 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 with weekly somatrogon followed by 12 weeks of treatment with daily Genotropin. Subjects will have study visits at Baseline, Weeks 6, 12, 18, and 24. Subjects will also be followed up by phone 8 to 12 days after each treatment period begins (Week 1 and Week 13). Subjects and caregivers (as a Dyad) will complete questionnaires assessing treatment burden at baseline and at the end of each 12 week treatment period. All subjects/caregivers will receive a follow up phone call at Week 28.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Growth Hormone Deficiency
Intervention  ICMJE
  • Drug: Genotropin
    Genotropin (dose [mg] at time of enrollment) given subcutaneously once daily
  • Drug: somatrogon
    0.66 mg/kg/week given subcutaneously once weekly
Study Arms  ICMJE
  • Daily to Weekly
    Genotropin to somatrogon
    Interventions:
    • Drug: Genotropin
    • Drug: somatrogon
  • Weekly to Daily
    somatrogon to Genotropin
    Interventions:
    • Drug: Genotropin
    • Drug: somatrogon
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 1, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 26, 2020
Estimated Primary Completion DateMarch 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Children aged 3 years old and <18 years with either isolated GHD, or GH insufficiency.
  2. 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.
  3. IGF I SDS < 2.
  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

  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 < 2 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 regularly scheduled daily or weekly injectable medications other than Genotropin® Pen, Genotropin GoQuick®, HumatroPen® (USA only), or Omnitrope® Pen (USA only).
  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.
  16. 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.
  17. Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.
  18. Patient and/or the parent/legal guardian are likely to be non-compliant with respect to study conduct.
  19. 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.
  20. Children with closed epiphyses (this determination can be based on available existing clinical data).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Czechia,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03831880
Other Study ID Numbers  ICMJE C0311002
2018?000918?38 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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

BY EMAIL

Contact

[email protected]

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