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
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency
Intervention: Non Interventional Study (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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.
Clinical Details
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 design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: 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.
Detailed description:
Patients within inclusion criteria are asked to participate in the study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Höglandssjukhuset, Eksjö SE-575 81, Sweden; Not yet recruiting
Landstinget Dalarna, Falun 791 82, Sweden; Recruiting
Sahlgrenska University hospital, Goteborg 413 45, Sweden; Recruiting
Landstinget i Kalmar Lan, Kalmar 392 85, Sweden; Recruiting
Central Hospital/ Department of Medicine, Kristianstad 291 85, Sweden; Recruiting
Universitetssjukhuset, EM-kliniken, Linköping 581 85, Sweden; Recruiting
Ljungby Lasarettet, Ljungby 341 82, Sweden; Recruiting
University Hospital SUS, Malmo 205 02, Sweden; Recruiting
Karolinska Universitetssjukhuset, Kliniken for Endokrinologi, Stockholm 171 76, Sweden; Recruiting
Landstinget i Stockholms Lan, Stockholm 118 83, Sweden; Not yet recruiting
Akademiska sjukhuset / Medicincentrum, Diabetes- och Endokrinsektionen, Uppsala 751 85, Sweden; Recruiting
Medicinkliniken, Centrallasarettet Vaxjo, Vaxjo 351 85, Sweden; Recruiting
Vastra Gotalands Regionen, Skovde, Skaraborg 541 85, Sweden; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2013
Last updated: August 5, 2015
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