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

Pfizer

Status

Completed

Conditions

Growth Hormone Deficiency

Treatments

Other: Non Interventional Study

Study type

Observational

Funder types

Industry

Identifiers

NCT01947894

SWEGHO (Other Identifier)

A6281313

Details and patient eligibility

About

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.

Full description

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

Enrollment

377 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.