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NCT03064074 · ClinicalTrials.gov registry record · Phase 1
Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03064074: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT03064074 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03064074, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Osteogenesis Imperfecta (OI) is a rare disorder that causes bones to break easily. People with OI may have broken bones with little or no trauma, dentinogenesis imperfecta (DI), and, in adult years, hearing loss. OI can range from very severe to very mild. The current standard-of-care for severe types of OI involves the use of IV medications (bisphosphonates) and surgery to put rods in bones to strengthen them. These therapies, although often life-saving, are new and very little is known about their long-term effects on bone and other body systems. Transforming growth factor beta (TGF-β) is a protein important in bone formation. Fresolimumab is an antibody that can silence TGF-β . In studies with mice with OI, it has been shown that silencing TGF-β can lead to higher bone mass, quality and strength. The purpose of this study is to determine if fresolimumab is safe in the treatment of OI.
Primary Outcome
Safety of single and repeat doses of fresolimumab will be assessed in adult patients with moderate to severe osteogenesis imperfecta
Interventions
- DRUG Fresolimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-11-15 |
| Est. Completion | 2022-07-04 |
| Phase | Phase 1 |
What the finished NCT03064074 record still lists
NCT03064074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Fresolimumab is the first listed.
NCT03064074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03064074 about?
NCT03064074 is a clinical study titled "Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta". Osteogenesis Imperfecta (OI) is a rare disorder that causes bones to break easily. People with OI may have broken bones with little or no trauma, dentinogenesis imperfecta (DI), and, in adult years, hearing loss. OI can range from very severe to very mild. The current standard-of-care for severe typ...
What is the current status of trial NCT03064074?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2017-11-15. Estimated completion is 2022-07-04.
What interventions are being tested in trial NCT03064074?
The interventions under investigation include: Fresolimumab (DRUG).
Who is sponsoring clinical trial NCT03064074?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03064074's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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