A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults (HypoCCS)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypopituitarism Pituitary Insufficiency Growth Hormone Deficiency, Adult |
Drug: Somatropin (rDNA origin) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Global Hypopituitary Control and Complications Study |
- Clinically significant adverse events during somatropin replacement therapy. [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: Yes ]
- Evaluate long-term benefits of somatropin replacement therapy with regard to cardiovascular risk factors. [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: Yes ]
- Evaluate long-term benefits of somatropin replacement therapy with regard to fracture incidence. [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: Yes ]
- Evaluate long-term benefits of somatropin replacement therapy with regard to quality of life as assessed by a disease-specific module of the Questions of Life Satisfaction (QLS-H). [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
DNA Addendum - implemented in Germany only. Germany: DNA sample is kept, if patient consented to German DNA Addendum
| Estimated Enrollment: | 8000 |
| Study Start Date: | September 2002 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Somatropin replacement treatment
Adult patients with growth hormone deficiency receiving somatropin replacement treatment.
|
Drug: Somatropin (rDNA origin)
Dose, frequency and duration are at discretion of attending physician, and determined on an individual patient basis.
Other Names:
|
|
No treatment
Adult patients with growth hormone deficiency receiving no somatropin replacement treatment.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Clinics, private practices
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
Contacts and Locations More Information
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01088399 History of Changes |
| Other Study ID Numbers: | 6448, B9R-MC-GDGA |
| Study First Received: | February 25, 2010 |
| Last Updated: | February 26, 2013 |
| Health Authority: | Austria: Ethikkommission Belgium: Institutional Review Board Canada: Ethics Review Committee Czech Republic: Ethics Committee France: French Data Protection Authority France: Haute Autorité de Santé Transparency Commission Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Hungary: Research Ethics Medical Committee Italy: Ethics Committee Japan: Institutional Review Board Japan: Ministry of Health, Labor and Welfare Netherlands: Independent Ethics Committee Spain: Ministry of Health Spain: Ethics Committee Sweden: Regional Ethical Review Board Sweden: Medical Products Agency United Kingdom: Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Dwarfism, Pituitary Hypopituitarism Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases |
Bone Diseases, Endocrine Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013