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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

Last updated on May 16, 2018

FOR MORE INFORMATION
Study Location
Vastra Gotalands Regionen
Skovde, Skaraborg, 541 85 Sweden
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Deficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01947894
Pfizer
Active, not recruiting
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

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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
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.

Patients within inclusion criteria are asked to participate in the study.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients wiht Growth Hormone Deficiency
Growth Hormone Deficiency
Other: Non Interventional Study
Non Interventional Study
Adult Growth Hormone deficient Patients
Patients with GHD on Genotropin® replacement therapy.
Intervention: Other: Non Interventional Study
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
372
December 2018
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01947894
A6281313
SWEGHO ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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