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Trial record 1 of 1 for:    NCT01947894
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A Prospective Non-Interventional Study Protocol With Primary Data Collection - Assessment Of The Long Term Treatment Outcomes Of Genotropin Treatment In Growth Hormone Deficiency (GHD) Patients

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ClinicalTrials.gov Identifier: NCT01947894
Recruitment Status : Completed
First Posted : September 23, 2013
Results First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 18, 2013
First Posted Date September 23, 2013
Results First Submitted Date October 29, 2019
Results First Posted Date November 20, 2019
Last Update Posted Date November 20, 2019
Actual Study Start Date November 20, 2013
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 29, 2019)
Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments [ Time Frame: Up to 5 years (after baseline visit) ]
IGF-I along with growth hormone helps promote normal bone and tissue growth and development. Categories for assessment for participant's post-baseline IGF-I values: (1) IGF-I LLN = if any of assessments of IGF-I post-baseline visit was lower than lower limit of normal (LLN); (2) IGF-I ULN = If any of assessments of IGF-I post-baseline visit was greater than upper level of normal (ULN); (3) IGF-I unknown = no IGF-I reported; (4) Within reference range = IGF-I levels within normal range. Following is normal reference range of IGF-I in nanogram per milliliter. 18 Years of age (Y): Male =162-541, Female =170-640; 19 Y: Male =138-442, Female =147-527; 20 Y: Male =122-384,Female =132-457; 21-25 Y=116-341; 26-30 Y=117-321; 31-35 Y=113-297; 36-40 Y=106-277; 41-45 Y =98-261; 46-50 Y=91-246; 51-55 Y=84-233; 56-60 Y=78-220; 61-65 Y=72-207; 66-70 Y=67-195; 71-75 Y=62-184; 76-80 Y=57-172; >80 Y=53-162. There was no differentiation for male and female in normal range of IGF-I after 20 years of age.
Original Primary Outcome Measures
 (submitted: September 9, 2013)
Non-Interventional study. [ Time Frame: no time frame ]
This Non-Interventional study does not include pre-specified endpoints, but collects information from adult subjects recieving Genotropin treatment in a real world clinic setting.
Change History
Current Secondary Outcome Measures
 (submitted: October 29, 2019)
  • Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 5 years ]
    An AE was any untoward medical occurrence in a participant who received Genotropin without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.
  • Number of Treatment Related Adverse Events [ Time Frame: Baseline up to 5 years ]
    Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. If there was any relationship between AE and Genotropin treatment,that was judged by investigator.
  • Number of Adverse Events Leading to Withdrawal of Genotropin Treatment [ Time Frame: Baseline up to 5 years ]
    An AE is any untoward medical occurrence in a participant administered a medicinal product that need not necessarily have a causal relationship with the product treatment or usage. An SAE is any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that resulted to death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); and congenital anomaly/birth defect.
  • Number of Participants Who Discontinued Study Due to Adverse Events [ Time Frame: Baseline up to 5 years ]
    An AE is any untoward medical occurrence in a participant administered a medicinal product that need not necessarily have a causal relationship with the product treatment or usage. An SAE is any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that resulted to death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); and congenital anomaly/birth defect. Participants who discontinued study due to AEs were reported.
  • Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 [ Time Frame: Baseline, Year 1, 2, 3, 4, 5 ]
    Weight of participants was measured in kilograms (kg).
  • Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 [ Time Frame: Baseline, Year 1, 2, 3, 4, 5 ]
    Weight of participants was measured in kg.
  • Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 [ Time Frame: Baseline, Year 1, 2, 3, 4, 5 ]
    Height of participants was measured in centimeters.
  • Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 [ Time Frame: Baseline, Year 1, 2, 3, 4, 5 ]
    Height of participants was measured in centimeters.
  • Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 [ Time Frame: Baseline, Year 1, 2, 3, 4, 5 ]
    BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2).
  • Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 [ Time Frame: Baseline, Year 1, 2, 3, 4, 5 ]
    BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in m^2.
  • Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 [ Time Frame: Baseline, Year 1, 2, 3, 4, 5 ]
    Measurement of BP included supine systolic blood pressure (SBP) and diastolic blood pressure (DBP).
  • Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 [ Time Frame: Baseline, Year 1, 2, 3, 4, 5 ]
    Measurement of BP included supine SBP and DBP.
  • Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 [ Time Frame: Baseline, Year 1, 2, 3, 4, 5 ]
    Heart rate was measured in supine position.
  • Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 [ Time Frame: Baseline, Year 1, 2, 3, 4, 5 ]
    Heart rate was measured in supine position.
  • Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ]
    Body composition included parameters fat mass and muscle mass.
  • Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 [ Time Frame: Baseline, Year 1, 2, 3, 4, 5 ]
    CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue and blood vessels. MRI investigation uses strong magnetic field and radio waves to create detailed images of the organs and tissues within the body.
  • Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ]
    Hormones that were evaluated were thyroid stimulating hormone, adrenocorticotropic hormone, luteinizing hormone, follicle-stimulating hormone, antidiuretic hormone and prolactin hormone. Abnormalities were judged by the investigator.
  • Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up [ Time Frame: Baseline, Follow-up (during 28 days after last dose of Genotropin treatment) ]
    Percentage of participants taking any medications other than Genotropin (concomitant medication) are reported.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective Non-Interventional Study Protocol With Primary Data Collection - Assessment Of The Long Term Treatment Outcomes Of Genotropin Treatment In Growth Hormone Deficiency (GHD) Patients
Official Title SWEGHO - A PROSPECTIVE NON INTERVENTIONAL STUDY PROTOCOL WITH PRIMARY DATA COLLECTION - ASSESSMENT OF THE LONG TERM TREATMENT OUTCOMES OF GENOTROPIN TREATMENT IN GHD PATIENTS IN SWEDEN
Brief Summary

The purpose of this study is to assess the long term treatment outcomes of Growth Hormone treatment in patients who are prescribed and treated with Genotropin. Also, plan to determine the relationships between clinical status, dosage schedule and response to Genotropin treatment.

This study will also contribute to our knowledge of adult Growth Hormone Deficiency, including transition period in Childhood Onset Growth Hormone Deficiency and its treatment.

Detailed Description Patients within inclusion criteria are asked to participate in the study.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients wiht Growth Hormone Deficiency
Condition Growth Hormone Deficiency
Intervention Other: Non Interventional Study
Non Interventional Study
Study Groups/Cohorts Adult Growth Hormone deficient Patients
Patients with GHD on Genotropin® replacement therapy.
Intervention: Other: Non Interventional Study
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 Completed
Actual Enrollment
 (submitted: October 29, 2019)
377
Original Estimated Enrollment
 (submitted: September 9, 2013)
900
Actual Study Completion Date October 31, 2018
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients of 18 years of age and above and fulfilling one of the three alternatives a-c below;

    1. Newly diagnosed with GHD according to the current medical standard.
    2. Diagnosed with GHD before 2013 and previously treated with Genotropin and followed in KIMS®.
    3. Transition patients diagnosed with CO-GHD before 2013.
  • Prescribed Genotropin at the time of inclusion.
  • Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  • Patients who participate in any concurrent clinical interventional trial where a non-authorized or authorized study medication is used, during their participation in Swedish KIMS® Xtended. Concurrent studies which do not include any study interventional items (whether medications or devices) are allowed.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT01947894
Other Study ID Numbers A6281313
SWEGHO ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
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
Plan to Share IPD: No
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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2019