A Study to Evaluate Long-Term Safety, Tolerability, & Efficacy of BMN 111 in Children With Achondroplasia (ACH)



Status:Active, not recruiting
Healthy:No
Age Range:7 - Any
Updated:6/2/2018
Start Date:January 26, 2016
End Date:October 2022

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A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children With Achondroplasia

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.


Inclusion Criteria:

- Have completed 24 months of BMN 111 treatment in Study 111-202.

- Parent(s) or guardian(s) are willing and able to provide written, signed informed
consent. Subjects under the age of majority are willing and able to provide written
assent (if required). Subjects who reach the age of majority in their country will be
asked to provide their own written consent upon reaching the legal age of majority.

- If sexually active, willing to use a highly effective method of contraception while
participating in the study.

- Females >= 10 years old or who have started menses must have a negative pregnancy test
at baseline and be willing to have additional pregnancy tests during the study

- Willing and able to perform all study procedures as physically possible

- Parents/caregivers willing to administer daily injections to the subjects and complete
the required training.

Exclusion Criteria:

- Requires any investigational agent prior to completion of study period.

- Have a condition or circumstance that, in the view of the Investigator, places the
subject at high risk for poor treatment compliance or for not completing the study.

- Concurrent disease or condition that, in the view of the Investigator, would interfere
with study participation or safety evaluations for any reason.

- Permanently discontinued BMN 111 during the 111-202 study.

- Subject is pregnant at Baseline visit or planning to become pregnant (self or partner)
at any time during the study.

- Current chronic therapy with restricted medications.
We found this trial at
7
sites
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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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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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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Oakland, CA
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1000 W Carson St
Torrance, California 90502
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Torrance, CA
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Baltimore, MD
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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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Parkville,
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