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 |
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.
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
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
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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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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1211 Medical Center Dr
Nashville, Tennessee 37232
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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225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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8701 West Watertown Plank Road
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
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