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Serostim (Somatropin) - Summary



Serostim® [somatropin (rDNA origin) for injection] is a human growth hormone (hGH) produced by recombinant DNA technology. Serostim® has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary GH. Serostim® is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the hGH gene.

HIV-Associated Wasting or Cachexia

Serostim® [somatropin (rDNA origin) for injection] is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance.  Concomitant antiretroviral therapy is necessary (see PRECAUTIONS).

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Published Studies Related to Serostim (Somatropin)

Cost-effectiveness of somatropin for the treatment of short children born small for gestational age. [2010.06]
BACKGROUND: Short children born small for gestational age (SGA) may be at increased risk for long-term morbidity and reduced health-related quality of life (HRQoL) due to their short stature. Normalization of height in childhood and adolescence is possible in such children via the use of the recombinant human growth hormone somatropin. OBJECTIVE: The aim of this study was to determine whether somatropin was a cost-effective treatment option in short children born SGA... CONCLUSION: In this model, somatropin was a cost-effective treatment option for short children born SGA from the perspective of the UK NHS.

Relative bioavailability of two drug products of somatropin obtained from either the milk of transgenic cows or bacterial culture. [2010]
BACKGROUND: Our objective was to assess the relative bioavailability of the first somatropin produced in transgenic cloned cows that carry the human growth hormone (GH) gene (Biohormon) and somatropin produced in Escherichia coli culture (HHT), the procedure most frequently used for the commercial production of the hormone... CONCLUSION: This study demonstrates that a single dose of Biohormon, the first product with somatropin obtained from milk of transgenic mammals, is bioequivalent to the reference product HHT according to standard criteria. Copyright (c) 2010 S. Karger AG, Basel.

Cost-effectiveness of somatropin for the treatment of short children born small for gestational age. [2010]
cost-effective treatment option in short children born SGA... CONCLUSION: In this model, somatropin was a cost-effective treatment option for

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.

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Clinical Trials Related to Serostim (Somatropin)

Safety and Efficacy Study of Serostim� Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome [Completed]
In Serono Study 24380, the antecedent protocol to Study 25373, patients were randomly assigned in a 3. 0-to-1. 0 ratio to Groups A and B. All patients in Group A received recombinant human growth hormone (Serostim) 4 mg daily (the "induction" phase) for the first 12 weeks, and then were re-randomized to receive either placebo or Serostim 2 mg on alternate days (roughly equivalent to 1 mg daily) during Weeks 12-36 (the "maintenance" phase). All patients in Group B initially received placebo from baseline to Week 24, and then received Serostim 4 mg daily from Weeks 24 to 36 (Grunfeld, 2007). In the follow-up Study 25373, any subject who was enrolled in Serono Study 24380 and was assigned to Group A, who fully completed all study visits without a major protocol violation, was eligible to enroll to receive re-treatment with Serostim at a dose of 4 mg daily for 12 weeks. During study 25373, safety was monitored by recording of adverse events and measurement of urinalysis and laboratory blood tests to assess fasting glucose, fasting insulin, and routine biochemistry and hematology parameters. At Week 12 or at the time of study termination, subjects underwent re-assessment of body composition via anthropometry measurements and dual photon absorptiometry (DXA) scanning. In addition, at study termination, measurements of insulin-like growth factor I (IGF-I), insulin-like growth binding protein 3 (IGFBP-3), fasting lipid profile, and oral glucose tolerance testing were obtained.

Safety and Efficacy Trial of Serostim� in the Treatment of Subjects With Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) [Completed]
This study is a Phase 2/3, multicenter, double-blind, randomized, parallel-group, placebo-controlled, dose-finding trial of Serostim (mammalian cell-derived recombinant human growth hormone, r-hGH) versus placebo in subjects with human immunodeficiency virus-associated adipose tissue redistribution syndrome (HARS). The primary study objective is to determine whether Serostim treatment reduces adipose tissue maldistribution more effectively than placebo. The primary co-endpoints are derived from measures of visceral adipose tissue assessed by computerized tomography (CT) and the ratio of trunk; and limb fat assessed by dual-energy X-Ray absorptiometry (DXA) scans. Anthropometric measures, physical exams, quality of life assessments, serial photographs, and various laboratory measures will be used to address secondary objectives. These secondary objectives relate to the impact of Serostim® on Physician and subject assessments of change in body shape, health-related quality of life, attitude towards medication compliance, metabolic markers, fat redistribution, and safety. On Day 1, eligible subjects will be randomized in a 1: 1:1 ratio to receive daily Serostim®, Serostim® and placebo given on alternate days, or daily placebo. Serostim® doses will be based on body weight, with a maximum dose of 4 milligram (mg). Therapy will continue for 12 weeks. Treatment will then be altered and the new treatment will be continued through Week 24. Interim Study Visits will be required at Weeks 2 and 4 (Treatment Period 1) and at Weeks 14 and 16 (Treatment Period 2). Subjects will be offered to be enrolled into a maintenance Protocol (Study 23056) at Week 24.

An Efficacy and Safety Trial of Serostim� in the Maintenance of the Treatment Effect Obtained During the Study of Serostim� in Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome [Completed]
This is an open-label, multi-center, randomized, parallel-group, maintenance trial of Serostim in subjects who have completed a prior Serostim Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) trial (Study 22388). The subjects, who encountered toxicity during the antecedent protocol, will be assigned to a 1 milligram (mg) dose. All other subjects will be randomized in 1: 1 ratio, to receive up to 2 mg or 4 mg of Serostim®, beginning from Day 1 of Week 1. Doses will be adjusted downward in subjects weighing less than 55 kilogram (kg). Serostim® therapy will be continued at the assigned doses through Week 12 (Period 1). Subjects, who will encounter toxicity during Period 1, will be assigned to the 1 mg group for Period 2. All other subjects will be randomized in a 1: 1 ratio to receive up to 2 mg or 1 mg of Serostim® on a weight adjusted basis. Period 2 therapy will begin on Day 1 of Week 13, continuing through Week 36. Study visits are required at Screening (that is, Final Visit of the antecedent trial), Day 1 of Week 1 (Baseline), and at Weeks 2, 6, 12, 14, 24, 30 and 36.

Saizen Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study [Terminated]
To assess the immunogenicity of Saizen solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).

Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments [Recruiting]
We, the researchers, have found that growth hormone deficiency is very common in patients with pseudohypoparathyroidism type 1a, which falls under the broader condition termed Albright hereditary osteodystrophy. Patients with pseudohypoparathyroidism type 1a typically are short and obese. Some of these patients are not short during childhood, but due to a combination of factors, they end up short as adults. We are evaluating the effect of growth hormone treatment in those patients with pseudohypoparathyroidism type 1a who are found to be growth hormone deficient. We hypothesize that growth hormone deficiency may contribute to the short stature and obesity found in this condition. We are also evaluating the effect of growth hormone on patients with pseudohypoparathyroidism type 1a who are not growth hormone deficient (ie., growth hormone sufficient). We are also evaluating neurocognitive and psychosocial functioning in participants with AHO in order to determine the specific impairments that are most common in the condition and to determine the best approach toward management.

Funding source - - FDA OOPD [R01 FD003409 (in no-cost extension year) and R01 FD002568 (which

has ended)]

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Reports of Suspected Serostim (Somatropin) Side Effects

Death (3)Iron Deficiency Anaemia (3)Malformation Venous (3)Carpal Tunnel Syndrome (3)Dieulafoy's Vascular Malformation (3)Respiratory Failure (3)Thrombosis (2)Bone Pain (2)Pain (2)Influenza Like Illness (2)more >>

Page last updated: 2013-02-10

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