HUMATROPE SUMMARY
HUMATROPE®
SOMATROPIN (rDNA ORIGIN) FOR INJECTION
VIALS and CARTRIDGES
Humatrope® (Somatropin, rDNA Origin, for Injection) is a polypeptide hormone of recombinant DNA origin.
INDICATIONS AND USAGE
Pediatric Patients -- Humatrope is indicated for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone.
Humatrope is indicated for the treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed.
Humatrope is indicated for the long-term treatment of idiopathic short stature, also called non-growth hormone-deficient short stature, defined by height SDS Adult Patients -- Humatrope is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
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Adult Onset: Patients who have growth hormone deficiency either alone, or 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 who have growth hormone deficiency confirmed as an adult before replacement therapy with Humatrope is started.
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NEWS HIGHLIGHTS
Published Studies Related to Humatrope (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.
Exercise capacity and hormonal response in adults with childhood onset growth hormone deficiency during long-term somatropin treatment. [1998.10]
Growth hormone (GH) deficiency in adults in associated with reduced muscular strength and peak oxygen uptake (peak Vo2). How these variables are influenced by long-term somatropin therapy in adults with childhood onset GH-deficiency has not been precisely defined...
Outcome of a four-year randomized study of daily versus three times weekly somatropin treatment in prepubertal naive growth hormone-deficient children. Genentech Study Group. [1996.05]
A comparison was made of the growth responses of prepubertal naive GH-deficient children who were randomly assigned to receive 0.3 mg/kg.week recombinant human GH administered either daily (QD) or three times weekly (TIW) over 4 yr. The effects of the two regimens on annual growth velocity, change in height SD score, bone maturation, and age at onset of puberty are presented as the mean +/- SD.
Clinical Trials Related to Humatrope (Somatropin)
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
Efficacy of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency [Completed]
Aim of this study is to define the possible benefits of growth hormone supplementation, in
patients with heart failure due to left ventricular systolic dysfunction and coexisting
growth hormone deficiency.
Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome [Recruiting]
This is a randomized controlled, parallel group, open label versus "no treatment" trial which
evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short
bowel syndrome. The total follow-up is 14 months; 4 months for each group after randomization;
At the end of the first four months: the treated group will be followed within 6 months, the
untreated group will receive compassionately rhGH for 4 months and followed-up for 6 months
after the end of the treatment period.
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.
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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