A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia



Status:Enrolling by invitation
Healthy:No
Age Range:Any
Updated:2/17/2019
Start Date:May 23, 2018
End Date:May 2021

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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia, Age 0 to < 60 Months

Study 111-206 is a Phase 2 randomized, double-blind, placebo-controlled clinical trial of BMN
111 in infants and young children with a diagnosis of Achondroplasia.


Inclusion Criteria:

- Diagnosis of ACH, confirmed by genetic testing

- Age 0 to < 60 months at study entry (Day 1)

- At least 6-month period of pretreatment growth assessment in Study 111-901 immediately
before study entry (cohort 1 & 2) or at least 3 months of observation prior to
treatment (cohort 3)

Exclusion Criteria:

- Subject weight < 5.0 kg (cohort 1 & 2) or < 4.0 kg (cohort 3)

- Treatment with growth hormone within 6-months prior to screening or prolonged
treatment (> 3 months) at any time

- Any history of spine or long-bone surgery or any bone-related surgery with chronic
complications

- Any history of limb-lengthening surgery or planned limb-lengthening during the study

- Fracture of the long bones within 6 months prior to screening
We found this trial at
9
sites
747 52nd St
Oakland, California 94609
(510) 428-3000
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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1000 W Carson St
Torrance, California 90502
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Torrance, CA
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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Decatur, Georgia 30033
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Decatur, GA
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8701 West Watertown Plank Road
Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Westmead, New South Wales 2145
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Westmead,
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