Trial · Observational
CompletedPhase not statedResults postedRegistry dataThis trial does not test a peptide that PepBank tracks.
Sweden
1 trial · 1 completed · 1 with posted results
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
NCT0194789420 Nov 2013 to 31 Oct 2018
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Other
Adult Growth Hormone deficient Patients
Patients with GHD on Genotropin® replacement therapy.
Outcomes the sponsor listed as primary.
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.
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | 11 |
| Naive Adult Onset GHD | 2 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | 4 |
| Group | Value (Participants) |
|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | 103 |
| Naive Adult Onset GHD | 17 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | 22 |
| Group | Value (adverse events) |
|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | 8 |
| Naive Adult Onset GHD | 2 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | 0 |
| Group | Value (adverse events) |
|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | 14 |
| Naive Adult Onset GHD | 2 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | 1 |
| Group | Value (Participants) |
|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | 5 |
| Naive Adult Onset GHD | 1 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | 0 |
| Group | Value (kg) | Spread |
|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | 83.8 | 16.76 |
| Naive Adult Onset GHD | 82.4 | 19.68 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | 86.9 | 26.11 |
| Group | Value (kg) | Spread |
|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | 0 | 6.55 |
| Naive Adult Onset GHD | -2.0 | 15.37 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | -2.3 | 21.49 |
| Group | Value (centimeters (cm)) | Spread |
|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD) | 171.7 | 9.39 |
| Naive Adult Onset GHD | 172.2 | 10.67 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD) | 171.7 | 11.81 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| KIMS Adult Onset Growth Hormone Deficiency (GHD)Participants were diagnosed with GHD before 2013, were previously treated with Genotropin and were followed in KIMS®. Participants continued to be diagnosed with GHD as per current medical standards, who aged greater than or equal to (\>=) 18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. KIMS® (Pfizer international metabolic database), have data for long-term safety and treatment outcomes of adult participants treated with Genotropin in a real-world clinical setting between 1994 and 2012. | 12 / 246 | 57 / 246 | 66 / 246 |
| Naive Adult Onset GHDParticipants who were newly diagnosed with GHD as per current medical standards, aged \>=18 years, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. | 1 / 41 | 5 / 41 | 14 / 41 |
| Childhood Onset Growth Hormone Deficiency (CO-GHD)Participants were diagnosed with CO-GHD before 2013. Participants aged \>=18 years and continued to be diagnosed with GHD as per current medical standards, received Genotropin treatment in a real world clinic setting as prescribed in clinical practice and were followed up/observed for long-term Genotropin therapy treatment outcomes in this study. | 0 / 87 | 10 / 87 | 15 / 87 |
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