A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults (HypoCCS)
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| First Received Date ICMJE | February 25, 2010 | ||||
| Last Updated Date | February 26, 2013 | ||||
| Start Date ICMJE | September 2002 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Clinically significant adverse events during somatropin replacement therapy. [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01088399 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults | ||||
| Official Title ICMJE | The Global Hypopituitary Control and Complications Study | ||||
| Brief Summary | The Hypopituitary Control and Complications Study "HypoCCS" is a prospective, open label, global, multicentre, observational study on routine clinical care of adults with growth hormone deficiency occurring either isolated or in combination with other pituitary hormone deficiencies. The objective of this observational study is to evaluate long-term safety and health outcomes for adult growth hormone deficient patients with or without somatropin replacement therapy. As an observational study, data are collected only as provided at the discretion of the attending physician. The patients enrolled meet the criteria of growth hormone deficiency in adults as per the Humatrope label in the country where their attending physician practices, and this diagnosis is at the discretion of the attending physician. The decision to receive somatropin or remain untreated is made by the patient in consultation with their attending physician. While treatment of adult growth hormone deficient patients with somatropin has been shown to be safe and effective in clinical trials of 18 months duration, this observational study aims to provide information on health outcome and replacement therapy over longer periods of time for a larger number of patients in the context of the overall disease environment. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: DNA Addendum - implemented in Germany only. Germany: DNA sample is kept, if patient consented to German DNA Addendum |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Clinics, private practices |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Somatropin (rDNA origin)
Dose, frequency and duration are at discretion of attending physician, and determined on an individual patient basis.
Other Names:
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| Study Group/Cohort (s) |
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| Publications * | Attanasio AF, Jung H, Mo D, Chanson P, Bouillon R, Ho KK, Lamberts SW, Clemmons DR; HypoCCS International Advisory Board. Prevalence and incidence of diabetes mellitus in adult patients on growth hormone replacement for growth hormone deficiency: a surveillance database analysis. J Clin Endocrinol Metab. 2011 Jul;96(7):2255-61. Epub 2011 May 4. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 8000 | ||||
| Completion Date | December 2012 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Adult growth hormone deficiency as per the local Humatrope label and as judged by the attending physician Exclusion Criteria: - As per the local Humatrope label and as judged by the attending physician |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01088399 | ||||
| Other Study ID Numbers ICMJE | 6448, B9R-MC-GDGA | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Eli Lilly and Company | ||||
| Study Sponsor ICMJE | Eli Lilly and Company | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Eli Lilly and Company | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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