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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 November 14, 2019

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
Completed
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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Descriptive Information
Brief TitleA 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 TitleSWEGHO - 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
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 DescriptionPatients within inclusion criteria are asked to participate in the study.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients wiht Growth Hormone Deficiency
ConditionGrowth Hormone Deficiency
InterventionOther: Non Interventional Study
Non Interventional Study
Study Groups/CohortsAdult Growth Hormone deficient Patients
Patients with GHD on Genotropin® replacement therapy.
Intervention: Other: Non Interventional Study
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: October 4, 2018)
378
Original Estimated Enrollment
 (submitted: September 9, 2013)
900
Actual Study Completion DateOctober 31, 2018
Actual Primary Completion DateOctober 31, 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesSweden
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01947894
Other Study ID NumbersA6281313
SWEGHO ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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