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Trial record 1 of 1 for:    NCT01947894
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01947894
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.


Condition or disease Intervention/treatment
Growth Hormone Deficiency Other: Non Interventional Study

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

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Study Type : Observational
Actual Enrollment : 378 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 20, 2013
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018


Group/Cohort Intervention/treatment
Adult Growth Hormone deficient Patients
Patients with GHD on Genotropin® replacement therapy.
Other: Non Interventional Study
Non Interventional Study




Primary Outcome Measures :
  1. 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. [ Time Frame: no time frame ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients wiht Growth Hormone Deficiency
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947894


Locations
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Sweden
Vastra Gotalands Regionen
Skovde, Skaraborg, Sweden, 541 85
Landstinget Dalarna
Falun, Sweden, 791 82
Sahlgrenska University hospital
Goteborg, Sweden, 413 45
Central Hospital/ Department of Medicine
Kristianstad, Sweden, 291 85
Universitetssjukhuset, EM-kliniken
Linköping, Sweden, 581 85
Ljungby Lasarettet
Ljungby, Sweden, 341 82
University Hospital SUS
Malmo, Sweden, 205 02
Landstinget i Stockholms Lan
Stockholm, Sweden, 118 83
Karolinska Universitetssjukhuset, Kliniken for Endokrinologi
Stockholm, Sweden, 171 76
Akademiska sjukhuset / Medicincentrum, Diabetes- och Endokrinsektionen
Uppsala, Sweden, 751 85
Landstinget i Jonkopings Lan
Varnamo, Sweden, 331 85
Medicinkliniken, Centrallasarettet Vaxjo
Vaxjo, Sweden, 351 85
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01947894     History of Changes
Other Study ID Numbers: A6281313
SWEGHO ( Other Identifier: Alias Study Number )
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs