Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 11 participants.
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.
Interventions
- DRUG Fresolimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-11-15 |
| Est. Completion | 2022-07-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03064074
The ClinicalTrials.gov registry entry for NCT03064074 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fresolimumab is the first listed.
NCT03064074 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.