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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

377 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-20

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Growth Hormone Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult Growth Hormone deficient Patients

Patients with GHD on Genotropin® replacement therapy.

Non Interventional Study

Intervention Type OTHER

Non Interventional Study

Interventions

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Non Interventional Study

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No