Clinical trial NCT01947894: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Deficiency
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-09-23
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients wiht Growth Hormone Deficiency

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.

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.

Primary outcomes:
measure: Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments
timeFrame: Up to 5 years (after baseline visit)
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 5 years
measure: Number of Treatment Related Adverse Events
timeFrame: Baseline up to 5 years
measure: Number of Adverse Events Leading to Withdrawal of Genotropin Treatment
timeFrame: Baseline up to 5 years
measure: Number of Participants Who Discontinued Study Due to Adverse Events
timeFrame: Baseline up to 5 years
measure: Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5
timeFrame: Baseline, Year 1, 2, 3, 4, 5
measure: Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5
timeFrame: Baseline, Year 1, 2, 3, 4, 5
measure: Height of Participants at Baseline, Years 1, 2, 3, 4 and 5
timeFrame: Baseline, Year 1, 2, 3, 4, 5
measure: Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5
timeFrame: Baseline, Year 1, 2, 3, 4, 5
measure: Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5
timeFrame: Baseline, Year 1, 2, 3, 4, 5
measure: Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5
timeFrame: Baseline, Year 1, 2, 3, 4, 5
measure: Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5
timeFrame: Baseline, Year 1, 2, 3, 4, 5
measure: Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5
timeFrame: Baseline, Year 1, 2, 3, 4, 5
measure: Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5
timeFrame: Baseline, Year 1, 2, 3, 4, 5
measure: Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5
timeFrame: Baseline, Year 1, 2, 3, 4, 5
measure: Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4
timeFrame: Baseline, Year 1, 2, 3, 4
measure: Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5
timeFrame: Baseline, Year 1, 2, 3, 4, 5
measure: Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4
timeFrame: Baseline, Year 1, 2, 3, 4
measure: Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up
timeFrame: Baseline, Follow-up (during 28 days after last dose of Genotropin treatment)
Other outcomes:
Locations:
city: Skovde
country: Sweden
facility: Vastra Gotalands Regionen
state: Skaraborg
city: Falun
country: Sweden
facility: Landstinget Dalarna
city: Goteborg
country: Sweden
facility: Sahlgrenska University hospital
city: Kristianstad
country: Sweden
facility: Central Hospital/ Department of Medicine
city: Linköping
country: Sweden
facility: Universitetssjukhuset, EM-kliniken
city: Ljungby
country: Sweden
facility: Ljungby Lasarettet
city: Malmo
country: Sweden
facility: University Hospital SUS
city: Stockholm
country: Sweden
facility: Landstinget i Stockholms Lan
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset, Kliniken for Endokrinologi
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset / Medicincentrum, Diabetes- och Endokrinsektionen
city: Varnamo
country: Sweden
facility: Landstinget i Jonkopings Lan
city: Vaxjo
country: Sweden
facility: Medicinkliniken, Centrallasarettet Vaxjo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: