Growth Hormone DeficiencyNCT01947894
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
An observational study of Growth Hormone Deficiency, run by Pfizer at 12 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Non Interventional Study
- How many people
- 377 participants
- Where
- 12 sitesSweden
- Study dates
- 20 Nov 2013to 31 Oct 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients wiht Growth Hormone Deficiency
Who may be able to join
- Adult patients of 18 years of age and above and fulfilling one of the three alternatives a-c below;
- Newly diagnosed with GHD according to the current medical standard.
- Diagnosed with GHD before 2013 and previously treated with Genotropin and followed in KIMS®.
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Sweden12 sites
Landstinget Dalarna
Falun, 791 82
Sahlgrenska University hospital
Gothenburg, 413 45
Central Hospital/ Department of Medicine
Kristianstad, 291 85
Universitetssjukhuset, EM-kliniken
Linköping, 581 85
Ljungby Lasarettet
Ljungby, 341 82
University Hospital SUS
Malmö, 205 02
Vastra Gotalands Regionen
Skövde, Skaraborg, 541 85
Landstinget i Stockholms Lan
Stockholm, 118 83
Karolinska Universitetssjukhuset, Kliniken for Endokrinologi
Stockholm, 171 76
Akademiska sjukhuset / Medicincentrum, Diabetes- och Endokrinsektionen
Uppsala, 751 85
Landstinget i Jonkopings Lan
Värnamo, 331 85
Medicinkliniken, Centrallasarettet Vaxjo
Vaxjo, 351 85
About this study
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
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.
Read the detailed description
Patients within inclusion criteria are asked to participate in the study.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Non Interventional Study
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Interventional StudyOther
Non Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| Adult Growth Hormone deficient Patients | Patients with GHD on Genotropin® replacement therapy. Receives: Other: Non Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years (after baseline visit)
Secondary outcomes (18)
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.
Measured: Baseline up to 5 years
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.
Measured: Baseline up to 5 years
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.
Measured: Baseline up to 5 years
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.
Measured: Baseline up to 5 years
Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5
Weight of participants was measured in kilograms (kg).
Measured: Baseline, Year 1, 2, 3, 4, 5
Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5
Weight of participants was measured in kg.
Measured: Baseline, Year 1, 2, 3, 4, 5
Height of Participants at Baseline, Years 1, 2, 3, 4 and 5
Height of participants was measured in centimeters.
Measured: Baseline, Year 1, 2, 3, 4, 5
Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5
Height of participants was measured in centimeters.
Measured: Baseline, Year 1, 2, 3, 4, 5
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).
Measured: Baseline, Year 1, 2, 3, 4, 5
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.
Measured: Baseline, Year 1, 2, 3, 4, 5
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).
Measured: Baseline, Year 1, 2, 3, 4, 5
Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5
Measurement of BP included supine SBP and DBP.
Measured: Baseline, Year 1, 2, 3, 4, 5
Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5
Heart rate was measured in supine position.
Measured: Baseline, Year 1, 2, 3, 4, 5
Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5
Heart rate was measured in supine position.
Measured: Baseline, Year 1, 2, 3, 4, 5
Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4
Body composition included parameters fat mass and muscle mass.
Measured: Baseline, Year 1, 2, 3, 4
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.
Measured: Baseline, Year 1, 2, 3, 4, 5
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.
Measured: Baseline, Year 1, 2, 3, 4
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.
Measured: Baseline, Follow-up (during 28 days after last dose of Genotropin treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study start20 Nov 2013
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947894
- Sponsor's protocol ID
- A6281313
- Other IDs
- SWEGHO
- Status last verified
- Oct 2019
- First submitted
- 18 Jun 2013
- Last updated
- 20 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01947894
- Acronym / sponsor ID
- A6281313
- Conditions
- Growth Hormone Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2013 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Posted 20 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Growth Hormone deficient Patients | – | Other: Non Interventional StudyPatients with GHD on Genotropin® replacement therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients wiht Growth Hormone Deficiency
Key inclusion criteria (6 listed)
- Adult patients of 18 years of age and above and fulfilling one of the three alternatives a-c below;
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Interventional StudyNon Interventional Study | Other | Adult Growth Hormone deficient Patients |
Primary outcome
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.
18 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 5 years
Number of Treatment Related Adverse Events
Time frame: Baseline up to 5 years
Number of Adverse Events Leading to Withdrawal of Genotropin Treatment
Time frame: Baseline up to 5 years
Number of Participants Who Discontinued Study Due to Adverse Events
Time frame: Baseline up to 5 years
Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5
Time frame: Baseline, Year 1, 2, 3, 4, 5
Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5
Time frame: Baseline, Year 1, 2, 3, 4, 5
Height of Participants at Baseline, Years 1, 2, 3, 4 and 5
Time frame: Baseline, Year 1, 2, 3, 4, 5
Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5
Time frame: Baseline, Year 1, 2, 3, 4, 5
Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5
Time frame: Baseline, Year 1, 2, 3, 4, 5
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
Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5
Time frame: Baseline, Year 1, 2, 3, 4, 5
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
Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5
Time frame: Baseline, Year 1, 2, 3, 4, 5
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
Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4
Time frame: Baseline, Year 1, 2, 3, 4
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
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
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency, run by Pfizer at 12 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments (time frame: Up to 5 years (after baseline visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.