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Last Updated: May 27, 2024

CLINICAL TRIALS PROFILE FOR OMNITROPE


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All Clinical Trials for OMNITROPE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00209235 ↗ Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments Recruiting Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2/Phase 3 2003-01-01 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 (i.e., growth hormone sufficient) in those who had been on study drug through R01 FD003409 or who meet the criteria of idiopathic short stature or SGA. 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 -- Growth hormone study: FDA OOPD [R01 FD003409 (which has ended) and R01 FD002568 (which has ended)] Cognitive/behavior: NICHD R21 HD078864
NCT00209235 ↗ Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments Recruiting Johns Hopkins University Phase 2/Phase 3 2003-01-01 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 (i.e., growth hormone sufficient) in those who had been on study drug through R01 FD003409 or who meet the criteria of idiopathic short stature or SGA. 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 -- Growth hormone study: FDA OOPD [R01 FD003409 (which has ended) and R01 FD002568 (which has ended)] Cognitive/behavior: NICHD R21 HD078864
NCT00209235 ↗ Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments Recruiting Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Phase 2/Phase 3 2003-01-01 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 (i.e., growth hormone sufficient) in those who had been on study drug through R01 FD003409 or who meet the criteria of idiopathic short stature or SGA. 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 -- Growth hormone study: FDA OOPD [R01 FD003409 (which has ended) and R01 FD002568 (which has ended)] Cognitive/behavior: NICHD R21 HD078864
NCT00537914 ↗ Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA) Active, not recruiting Sandoz Phase 4 2008-02-06 This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).
NCT01247675 ↗ A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency Completed Ascendis Pharma A/S Phase 2 2010-11-01 This study investigates the safety, tolerability, pharmacokinetic profile (PK), and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth hormone product over a period of 4 weeks (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone Deficiency.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for OMNITROPE

Condition Name

Condition Name for OMNITROPE
Intervention Trials
Small for Gestational Age 1
Adult Growth Hormone Deficiency 1
Albright Hereditary Osteodystrophy 1
Female Infertility Due to Diminished Ovarian Reserve 1
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Condition MeSH

Condition MeSH for OMNITROPE
Intervention Trials
Pseudopseudohypoparathyroidism 1
Pseudohypoparathyroidism 1
Infertility, Female 1
Infertility 1
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Clinical Trial Locations for OMNITROPE

Trials by Country

Trials by Country for OMNITROPE
Location Trials
Poland 7
Germany 3
United States 2
Czechia 2
Hungary 2
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Trials by US State

Trials by US State for OMNITROPE
Location Trials
New York 1
Maryland 1
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Clinical Trial Progress for OMNITROPE

Clinical Trial Phase

Clinical Trial Phase for OMNITROPE
Clinical Trial Phase Trials
Phase 4 1
Phase 2/Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for OMNITROPE
Clinical Trial Phase Trials
Enrolling by invitation 1
Recruiting 1
Active, not recruiting 1
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Clinical Trial Sponsors for OMNITROPE

Sponsor Name

Sponsor Name for OMNITROPE
Sponsor Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 1
Johns Hopkins University 1
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. 1
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Sponsor Type

Sponsor Type for OMNITROPE
Sponsor Trials
Other 3
Industry 2
NIH 1
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