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Sponsored by: |
Altus Pharmaceuticals |
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Information provided by: | Altus Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00297713 |
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.
Condition | Intervention | Phase |
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Adult Growth Hormone Deficiency |
Drug: ALTU-238 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Phase II, Multi-Center, Multi-Dose, Randomized, Open-Label, Parallel Group 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 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Growth hormone deficiency as determined by pituitary testing within the last five years by either of the two following tests:
Exclusion Criteria:
United States, Kentucky | |
University of Louisville | |
Louisville, Kentucky, United States, 40202 | |
United States, Texas | |
Diabetes and Glandular Disease Clinic | |
San Antonio, Texas, United States, 78229 | |
University of Texas Medical Branch | |
Galveston, Texas, United States, 77555 |
Study ID Numbers: | 230-00009 |
Study First Received: | February 27, 2006 |
Last Updated: | December 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00297713 |
Health Authority: | United States: Food and Drug Administration |
Dwarfism Bone Diseases, Endocrine Hypopituitary dwarfism Hypothalamic Diseases Pituitary Diseases Central Nervous System Diseases Endocrine System Diseases Dwarfism, Pituitary |
Brain Diseases Bone Diseases Growth hormone deficiency Musculoskeletal Diseases Hypopituitarism Bone Diseases, Developmental Endocrinopathy |
Nervous System Diseases |