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NCT03393975 · ClinicalTrials.gov registry record · Phase 3
A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP)
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 52
- Enrollment target
NCT03393975 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 52 participants.
The verdict
NCT03393975, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 52 participants
- Enrollment target
Study Summary
Thrombotic thrombocytopenic purpura (or TTP for short) is a condition where blood clots form in small blood vessels throughout the body. The clots can limit or block the flow of oxygen-rich blood to the body's organs, such as the brain, kidneys, and heart. As a result, serious health problems can develop. The increased clotting that occurs in TTP uses up the cells that help the blood to clot, called platelets. With fewer platelets available in the blood, bleeding problems can occur. People who have TTP may bleed underneath the skin forming purple bruises or purpura, or from the surface of the skin. TTP also can cause anemia, a condition in which red blood cells break apart faster than the body can replace them leading to lower than normal number of red blood cells. A lack of activity in the ADAMTS13 enzyme, a protein in the blood involved in blood clotting, causes TTP. The enzyme breaks up another blood protein called von Willebrand factor that clumps together with platelets to form blood clots. Some people are born with this condition, others get the condition during their life. Many people who born with TTP experience frequent flareups that need to be treated right away. If not treated It can be fatal or cause lasting damage, such as brain damage or a stroke. BAX 930 is a medicine that replaces ADAMTS13 and can prevent or control TTP flareups, called TTP events. The main aim of this study is to compare the number of TTP events in people born with severe TTP when they treated with BAX 930 versus when they are treated with the standard treatment. Treatment will be given in 2 ways: * BAX 930 or standard treatment given to prevent TTP events from happening. * BAX 930 or standard treatment given to control an acute TTP event when it happens, according to the clinic's standard practice. Both BAX 930 and standard treatment are given slowly through a vein (infusion). At the first visit, the study doctor will check if you can participate in the study. If you are eligi
Interventions
- BIOLOGICAL TAK-755
- BIOLOGICAL Standard of care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2017-10-13 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03393975
The ClinicalTrials.gov registry entry for NCT03393975 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TAK-755 is the first listed.
NCT03393975 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03393975 about?
NCT03393975 is a clinical study titled "A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP)". Thrombotic thrombocytopenic purpura (or TTP for short) is a condition where blood clots form in small blood vessels throughout the body. The clots can limit or block the flow of oxygen-rich blood to the body's organs, such as the brain, kidneys, and heart. As a result, serious health problems can de...
What is the current status of trial NCT03393975?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2017-10-13. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT03393975?
The interventions under investigation include: TAK-755 (BIOLOGICAL), Standard of care (BIOLOGICAL).
Who is sponsoring clinical trial NCT03393975?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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