BMN 111
DrugBMN 111 will be administered subcutaneously daily.
Other names: Modified recombinant human C-type natriuretic peptide, Vosoritide
NCT Number: NCT02724228
This is a Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children with Achondroplasia. The primary objective is to evaluate the long-term safety and tolerability of daily SC injections of BMN 111 in children with ACH who have completed two years of treatment in the 111-202 study.
This study is active but is not currently recruiting participants.
7 year and older
All sexes
Interventional
Phase 2
Murdoch Children's Research Institute, Parkville, Victoria, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BMN 111 will be administered subcutaneously daily.
Other names: Modified recombinant human C-type natriuretic peptide, Vosoritide
Time frame: Until near final adult height is reached, and up to at least 16 years of age for females and 18 years of age for males, whichever occurs later
Time frame: Until near final adult height is reached
Annualized growth velocity (cm/yr)
Time frame: Until near final adult height is reached, and up to at least 16 years of age for females and 18 years of age for males, whichever occurs later
Height standard score (Z-score)
Time frame: Until near final adult height is reached, and up to at least 16 years of age for females and 18 years of age for males, whichever occurs later
Upper-to-lower body segment ratio
Time frame: Up to at least 16 years of age for females and 18 years of age for males
Height at the age of 16 years for females and 18 years for males
BioMarin Pharmaceutical
Industry
A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children With Achondroplasia
Acronym: ACH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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