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SAR439459 for Osteogenesis Imperfecta
Study Summary
This trial will test the safety of a new drug, SAR439459, in adults with OI. The study will also look at how well the drug works and what effects it has on the body.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have Type I or IV osteogenesis imperfecta with a known genetic cause.You have given your written permission to participate in the study.I am using birth control, not pregnant, not breastfeeding, and if male, not donating sperm.My body weight is at least 30 kg.I have had at least one bone fracture in the last 10 years or two since turning 18.
- Group 1: SAR439459
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many research centers are overseeing this experiment?
"Patients interested in this trial may attend Baylor College of Medicine in Houston, Texas (Site Number: 8400003), Investigational Site Number 8400001 in Albuquerque, New mexico or Bone Research and Education Centre_Site Number :1240003 located in Oakville, Ontario. Additionally there are 7 other medical centres that patients can visit to join the study."
Does SAR439459 possess regulatory consent from the US Food and Drug Administration?
"Based on the limited data available, SAR439459 has been assigned a safety rating of 1. This is due to this being an early-phase trial with minimal information about its efficacy and security."
Are enrollment opportunities still available for this clinical trial?
"Affirmative. The information on clinicaltrials.gov suggests that the trial, which was originally posted on August 25th 2022, is actively searching for 24 volunteers from 7 different sites."
Are adults past the age of 20 considered suitable candidates for this experiment?
"This research trial is admitting individuals who are under 65 years of age and have reached the legal age of consent."
How many participants are engaged in this medical experiment?
"Affirmative. Data located on clinicaltrials.gov affirms that this research initiative, initially posted 25th of August 2022, is actively searching for volunteers. 24 participants are needed from 7 respective sites."
What are the qualifications for joining this research initiative?
"This trial is seeking 24 individuals with lobstein's disease between 18 and 65 years old. Qualified patients can expect to be included in the study."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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