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Sponsors and Collaborators: |
BioPartners GmbH LG Life Sciences |
Information provided by: | BioPartners GmbH |
ClinicalTrials.gov Identifier: | NCT00600808 |
Annualised height velocity after 12/24 months treatment and HV SDS height velocity after 12/24 months treatment expressed as number of standard deviations difference from the mean population height velocity for the appropriate gender and chronological age.
Condition | Intervention | Phase |
Growth Hormone Deficiency |
Drug: BPLG-003 |
Phase II Phase III |
Drug Information available for: | Somatotropin Somatropin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II/IIIa, Assessor Blinded (Partially Blinded), Randomised, Active-Controlled, Multicentre, Parallel-Group Study of the Safety, Efficacy and pk/pd of LB03002 Administered Weekly in Children With Growth Failure Due to GH Deficiency. |
Enrollment: | 51 |
Study Start Date: | June 2003 |
Study Completion Date: | June 2006 |
To evaluate the safety, efficacy and pharmacokinetics/ pharmacodynamics of LB03002 in the treatment of growth failure in children with growth hormone deficiency (GHD) and to determine the dose for a subsequent phase IIIb BPLG-004 study
Ages Eligible for Study: | 4 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | BPLG-003 |
First Received: | July 23, 2007 |
Last Updated: | January 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00600808 |
Health Authority: | Hungary: National Institute of Pharmacy; Russia: Ethics Committee; Poland: Ministry of Health; Serbia: Ethics Committee; Ukraine: Ministry of Health; Romania: National Medicines Agency |
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