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
NCT01947894
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FOR MORE INFORMATION
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | 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 | ||||
| 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 | ||||
| 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 Description | Patients within inclusion criteria are asked to participate in the study. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients wiht Growth Hormone Deficiency | ||||
| Condition | Growth Hormone Deficiency | ||||
| Intervention | Other: Non Interventional Study
Non Interventional Study | ||||
| Study Groups/Cohorts | Adult 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 Status | Completed | ||||
| Actual Enrollment | 377 | ||||
| Original Estimated Enrollment | 900 | ||||
| Actual Study Completion Date | October 31, 2018 | ||||
| Actual Primary Completion Date | October 31, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Sweden | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT01947894 | ||||
| Other Study ID Numbers | A6281313 SWEGHO ( Other Identifier: Alias Study Number ) | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | October 2019 | ||||