SAIZEN SUMMARY
Saizen ®
[somatropin (rDNA origin) for injection]
For subcutaneous or intramuscular injection
Saizen® [somatropin (rDNA origin) for injection] is a human growth hormone produced by recombinant DNA technology.
Pediatric Patients
Saizen® [somatropin (rDNA origin) for injection] is indicated for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Adult Patients
Saizen® [somatropin (rDNA origin) for injection] is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
Adult Onset: Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
In general, confirmation of the diagnosis of adult growth hormone deficiency in both groups usually requires an appropriate growth hormone stimulation test. However, confirmatory growth hormone stimulation testing may not be required in patients with congenital/genetic growth hormone deficiency or multiple pituitary hormone deficiencies due to organic disease.
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NEWS HIGHLIGHTS
Published Studies Related to Saizen (Somatropin)
Effect of the inhaled corticosteroid mometasone on small airway patency in patients with asthma. [2009.05]
The inflammation in asthma involves both the large and the small airways. This study was designed to examine whether mometasone delivered from a dry powder inhaler would improve those parameters thought to reflect patency and obstruction of the small airways (diameter <2 mm)... Mometasone delivered by a dry powder inhaler improved asthma control and pulmonary function in tests reflecting both large and small airways.
Clinical Trials Related to Saizen (Somatropin)
Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-Onset Growth Hormone Deficiency [Completed]
The primary objective is to evaluate the efficacy and safety of two different dose regimens
of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during
the transition phase from childhood to adulthood.
Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency [Completed]
To evaluate long-term safety of growth hormone replacement in adult patients with growth
hormone deficiency
Predictive Markers in GHD and TS Children Treated With SAIZEN® [Completed]
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.
Effect of Growth Hormone in Children With Growth Hormone Deficiency [Completed]
This trial was conducted in the United States of America (USA).
The purpose of the trial was to compare the effect of Norditropin® using different dosing
regimens in children suspected of growth hormone deficiency.
Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women [Completed]
The purpose of the study is to evaluate the effects of growth hormone replacement on women
with growth hormone deficiency. Growth hormone deficiency means the body no longer produces
growth hormone due to a tumor or some kind of disease of the brain in an area called the
pituitary/hypothalamic region. This is the area of the brain where growth hormone is
normally produced. We, the researchers at Massachusetts General Hospital, will establish the
effects of growth hormone replacement on cardiovascular parameters (laboratory tests, the
flexibility of the arteries, changes in heart rate) in women with growth hormone deficiency.
Our goal is to see if this therapy:
- has effects on women's cardiovascular risk markers (special blood tests which indicate
how healthy the heart and arteries are)
- has effects on women's types and levels of various substances circulating in their
blood
- in women affects the stiffness of their arteries and heart rate variability in parallel
with changes in cardiovascular risk markers
- has different effects depending on whether women are pre or post menopausal.
Participation in this study is expected to last approximately 12 months.
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