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| Sponsor: | Merck KGaA |
|---|---|
| Information provided by: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT00256126 |
Purpose
The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children. The study will recruit approximately 360 children in several countries worldwide. The study lasts for about the first one month of daily growth hormone treatment. There will be three clinic visits during the month of the study. There is an initial visit, then a visit before growth hormone treatment starts and finally a visit at the fourth week of treatment. The study requires two additional blood tests to a regular Saizen treatment follow-up. One sample is taken before growth hormone injections start and one additional blood sample is taken at the fourth week of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Growth Hormone Deficiency |
Drug: Saizen |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN® |
| Enrollment: | 318 |
| Study Start Date: | May 2005 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Saizen
blood sampling (10 ml) at baseline and one month (10 ml)
|
Eligibility| Ages Eligible for Study: | 2 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A)GHD: documented pre-established diagnosis of GHD with a GH peak response of <10 μg/L with 2 GH stimulation tests, without priming with oestradiol.
B)Turner syndrome: documented pre-established diagnosis by karyotype.
Exclusion Criteria:
Contacts and Locations| Argentina | |
| Local Medical Information Office | |
| Buenos Aires, Argentina | |
| Australia | |
| Local Medical Information Office | |
| Sydney, Australia | |
| Austria | |
| Local Medical Information Office | |
| Vienna, Austria | |
| Canada | |
| Local Medical Information Office | |
| Mississauga, Canada | |
| France | |
| Local Medical InformationOffice | |
| Paris, France | |
| Germany | |
| Local Medical Information Office | |
| Munich, Germany | |
| Italy | |
| Local Medical Information Office | |
| Rome, Italy | |
| Norway | |
| Local Medical Information Office | |
| Oslo, Norway | |
| Russian Federation | |
| Local Medical Information Office | |
| Russia, Russian Federation | |
| Singapore | |
| Local Medical Information Office | |
| Singapore, Singapore | |
| Spain | |
| Local Medical Information Office | |
| Madrid, Spain | |
| Sweden | |
| Local Medical Information Office | |
| Stockholm, Sweden | |
| United Kingdom | |
| Local Medical Information Office | |
| Feltham, United Kingdom | |
| Study Chair: | Clement Olivier | Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany |
More Information
| Responsible Party: | Clement Olivier, Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany |
| ClinicalTrials.gov Identifier: | NCT00256126 History of Changes |
| Other Study ID Numbers: | 24531 |
| Study First Received: | November 18, 2005 |
| Last Updated: | April 14, 2010 |
| Health Authority: | United Kingdom: National Health Service |
|
Dwarfism, Pituitary Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine |
Hypopituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |