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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01947894
Other study ID # A6281313
Secondary ID SWEGHO
Status Completed
Phase
First received
Last updated
Start date November 20, 2013
Est. completion date October 31, 2018

Study information

Verified date October 2019
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Patients within inclusion criteria are asked to participate in the study.


Recruitment information / eligibility

Status Completed
Enrollment 377
Est. completion date October 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 KIMSĀ®.

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 KIMSĀ® Xtended. Concurrent studies which do not include any study interventional items (whether medications or devices) are allowed.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non Interventional Study
Non Interventional Study

Locations

Country Name City State
Sweden Landstinget Dalarna Falun
Sweden Sahlgrenska University hospital Goteborg
Sweden Central Hospital/ Department of Medicine Kristianstad
Sweden Universitetssjukhuset, EM-kliniken Linköping
Sweden Ljungby Lasarettet Ljungby
Sweden University Hospital SUS Malmo
Sweden Vastra Gotalands Regionen Skovde Skaraborg
Sweden Karolinska Universitetssjukhuset, Kliniken for Endokrinologi Stockholm
Sweden Landstinget i Stockholms Lan Stockholm
Sweden Akademiska sjukhuset / Medicincentrum, Diabetes- och Endokrinsektionen Uppsala
Sweden Landstinget i Jonkopings Lan Varnamo
Sweden Medicinkliniken, Centrallasarettet Vaxjo Vaxjo

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments 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. Up to 5 years (after baseline visit)
Secondary Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) 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. Baseline up to 5 years
Secondary Number of Treatment Related Adverse Events 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. Baseline up to 5 years
Secondary Number of Adverse Events Leading to Withdrawal of Genotropin Treatment 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. Baseline up to 5 years
Secondary Number of Participants Who Discontinued Study Due to Adverse Events 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. Baseline up to 5 years
Secondary Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 Weight of participants was measured in kilograms (kg). Baseline, Year 1, 2, 3, 4, 5
Secondary Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 Weight of participants was measured in kg. Baseline, Year 1, 2, 3, 4, 5
Secondary Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 Height of participants was measured in centimeters. Baseline, Year 1, 2, 3, 4, 5
Secondary Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 Height of participants was measured in centimeters. Baseline, Year 1, 2, 3, 4, 5
Secondary Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 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). Baseline, Year 1, 2, 3, 4, 5
Secondary Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 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. Baseline, Year 1, 2, 3, 4, 5
Secondary Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 Measurement of BP included supine systolic blood pressure (SBP) and diastolic blood pressure (DBP). Baseline, Year 1, 2, 3, 4, 5
Secondary Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 Measurement of BP included supine SBP and DBP. Baseline, Year 1, 2, 3, 4, 5
Secondary Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 Heart rate was measured in supine position. Baseline, Year 1, 2, 3, 4, 5
Secondary Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 Heart rate was measured in supine position. Baseline, Year 1, 2, 3, 4, 5
Secondary Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 Body composition included parameters fat mass and muscle mass. Baseline, Year 1, 2, 3, 4
Secondary Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 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. Baseline, Year 1, 2, 3, 4, 5
Secondary Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 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. Baseline, Year 1, 2, 3, 4
Secondary Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up Percentage of participants taking any medications other than Genotropin (concomitant medication) are reported. Baseline, Follow-up (during 28 days after last dose of Genotropin treatment)
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