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Osteogenesis Imperfecta - Healing Genes
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Osteogenesis Imperfecta

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Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta

Multicenter Study to Evaluate Safety of Fresolimumab in Adults With Moderate-to-severe Osteogenesis Imperfecta


Phase 1

DESCRIPTION:

Researchers in OR and TX seek participants for a trial of an investigatory drug, Fresolimumab, for Osteogenesis Imperfecta. TGF-β is a protein important in bone formation. Studies have shown that increased TGF-β activity leads to lower bone mass and strength and increased fractures. Fresolimumab is an antibody that can silence TGF-β. This study seeks to explore the best dosage for the antibody: once, twice per year, or four times per year.

The study will require only visits for the injection of the drug and physical and lab assessments, for the frequency assigned over 12-month period.


PATIENT MUST:

  • Be 18 years of age or older
  • Have confirmed diagnosis of moderate-to-severe OI
  • Meet genetic screening requirements

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Antibody infusion at each study visit, along with physical and lab assessments.
  3. Visits will be required a maximum of 4 times in a 12 month period.

LOCATIONS AND CONTACTS:

The study sites are at Oregon Health Science University in Portland, OR (Map), and Baylor College of Medicine in Houston, TX (Map).

Contact: Dianne Dang  |  713-798-6694  |  [email protected]

 

SPONSOR INFORMATION:

Baylor College of Medicine

Genzyme, a Sanofi Company

Shriners Hospitals for Children

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Hospital for Special Surgery, New York

University of California, Los Angeles

University of Nebraska

Oregon Health and Science University

University of South Florida

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03064074

 

 

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