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Dwarfism, Pituitary clinical trials

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NCT ID: NCT00308464 Terminated - Clinical trials for Growth Hormone Deficiency

A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency

Start date: July 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.

NCT ID: NCT00297713 Completed - Clinical trials for Adult Growth Hormone Deficiency

Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety

Start date: July 2005
Phase: Phase 2
Study type: Interventional

ALTU-238 is a long acting crystalline formulation of recombinant human growth hormone (rhGH) that is being developed for the treatment of growth hormone deficiency in adults and children. ALTU-238 is designed to require fewer injections than the currently available formulations of rhGH.

NCT ID: NCT00294619 Completed - Clinical trials for Adult Growth Hormone Deficiency

Treatment of Adults With Growth Hormone Deficiency

Start date: April 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety profile of a new weekly administered growth hormone preparation compared with placebo in adults with growth hormone deficiency.

NCT ID: NCT00271518 Active, not recruiting - Clinical trials for Growth Hormone Deficiency (GHD)

Treatment of Children With Insufficient Secretion of Growth Hormone

BPLG-004
Start date: September 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare a new weekly administered growth hormone preparation with standard daily treatment in children with insufficient secretion of growth hormone

NCT ID: NCT00263445 Terminated - Clinical trials for Growth Hormone Deficiency

Constructing an Insulin-Like Growth Factor-based Prediction Model

Start date: August 2004
Phase: Phase 1/Phase 2
Study type: Observational

Serum insulin-like growth factor-I (IGF-I) measurements have been shown to correlate well with growth hormone action and effect, and recent data show that serum IGF-I may be related to safety and efficacy of growth hormone (GH) treatment in patients. Some studies indicate that high IGF-I levels are associated with increased cancer risk, and low IGF-I levels are associated with increased risk for cardiovascular disease. Studies in children also show that the serum IGF-I level is correlated with the change in height score achieved (that is, the higher the IGF-I level, the greater the gain in height). Pediatric endocrinologists have therefore begun to use serum IGF-I levels, in addition to growth rate and weight gain, to adjust the GH dose in treated children. Although monitoring of serum IGF-I levels is becoming standard of care in patients begin treated with GH, there are few guidelines regarding the actual logistics of adjusting GH dose. As serum IGF-I level has been linked to both safety and efficacy of GH treatment, the ideal practice would be to maintain serum IGF-I levels within a certain target range. The overall goal of our study is to construct a mathematical model which predicts the change in GH dose necessary to achieve a desired change in IGF-I level. Hypotheses to be tested by our study include the following: IGF-I measurement has a role in optimization of GH therapy; GH dose change to achieve IGF-I changes are predictable; and gender and puberty affect the relationship between dose change and target IGF-I changes.

NCT ID: NCT00262249 Completed - Clinical trials for Growth Hormone Disorder

Effect of Growth Hormone in Children With Growth Hormone Deficiency

Start date: August 2000
Phase: Phase 3
Study type: Interventional

This trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.

NCT ID: NCT00256126 Completed - Clinical trials for Growth Hormone Deficiency

Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®

Start date: May 31, 2005
Phase: Phase 4
Study type: Interventional

The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children.

NCT ID: NCT00235599 Completed - Clinical trials for Growth Hormone Deficiency

The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.

Start date: September 2005
Phase: N/A
Study type: Observational

This project is designed to answer the question: Is there an acute IGFBP-3 response in normal children? Our specific hypothesis states that under the influence of growth hormone secretagogues, intact IGFBP-3 molecule will undergo proteolysis and liberate IGFBP-3 fragments, along with other components of the ternary complex. This proteolysis will result in measurable rise in IGFBP-3, which will indicate the subject’s growth hormone status. Short children with growth hormone deficiency will not show an IGFBP-3 response.

NCT ID: NCT00212758 Completed - Clinical trials for Kidney Failure, Chronic

A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood

Start date: January 2005
Phase: Phase 4
Study type: Interventional

Treatment with growth hormone (GH; a hormone made by the body that stimulates growth) has been shown to be helpful in treating children with chronic kidney disease who fail to grow. The amount of growth that is seen in children treated with growth hormone varies widely for unknown reasons. Growth hormone works by producing another hormone in the liver called insulin-like growth factor-1, or IGF-1 for short. IGF-1 stimulates the bones to grow. The amount of IGF-1 in the blood may directly affect the amount of growth in each child. At this time, growth hormone therapy in children depends on giving a certain dose of growth hormone for each child based on his or her weight. If after 3-6 months on this dose of growth hormone the change in height is not enough, then the dose of growth hormone is increased until enough growth is seen. This method of dosing of growth hormone may take a long time and is complicated and time-consuming. The purpose of this study is to measure the amount of IGF-1 produced by the body as a result of giving 2 different doses of growth hormone in children for 7 days only. The study investigator hopes to find the most favorable level of IGF-1 generated after 7 days of growth hormone that correlates with good growth of children with kidney disease. Then instead of dosing growth hormone by weight, like is done now, researchers can dose growth hormone by the amount of IGF-1 that the body produces. Being able to dose more effectively will save valuable time for the child to grow and will shorten the overall duration of growth hormone therapy. The investigators will also determine the effect of inflammatory cytokines Il-6 and TNF-alpha on growth hormone insensitivity and hence IGF-1 generation test in the same population.

NCT ID: NCT00191360 Completed - Clinical trials for Adult Growth Hormone Deficiency

Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency

Start date: January 2003
Phase: Phase 3
Study type: Interventional

To evaluate long-term safety of growth hormone replacement in adult patients with growth hormone deficiency