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NCT01485055 · ClinicalTrials.gov registry record · Phase 2
Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease
A Phase 2 study, sponsored by Nationwide Children's Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01485055 is a Phase 2 study that was terminated before completion, run by Nationwide Children's Hospital. The registered enrollment target is 11 participants.
The verdict
NCT01485055, a Phase 2 study, was terminated before completion, sponsored by Nationwide Children's Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
Acute Graft Versus Host Disease (GVHD) is a serious medical condition that is a common development after Bone Marrow Transplant (BMT). Acute GVHD happens when the donor cells attack and damage your tissues and organs after transplant. Acute GVHD often causes: Skin rashes, nausea, vomiting, abdominal pain, diarrhea (may have blood), liver damage that can cause inflammation in the liver or jaundice (yellowing of the skin or eyes), damage to other organs Steroids are the first line of treatment for acute GVHD. About a quarter of the patients that develop acute GVHD may not respond to steroid and have steroid refractory GVHD (SR-aGVHD). Patients with SR-aGVHD may need other medications. SR-aGVHD, is a potentially life threatening condition. There is no standard treatment and it may not respond to treatment. The goals of this study are to find out if Infliximab and basiliximab can treat SR-aGVHD. Participants in this study will receive combination therapy (2 drugs: infliximab and basiliximab) once a week for four weeks.
Interventions
- DRUG Infliximab and Basiliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-12 |
| Est. Completion | 2016-09-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01485055
The ClinicalTrials.gov registry entry for NCT01485055 describes a study currently listed as terminated, categorized as Phase 2. 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 Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Infliximab and Basiliximab is the first listed.
NCT01485055 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01485055 about?
NCT01485055 is a clinical study titled "Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease". Acute Graft Versus Host Disease (GVHD) is a serious medical condition that is a common development after Bone Marrow Transplant (BMT). Acute GVHD happens when the donor cells attack and damage your tissues and organs after transplant. Acute GVHD often causes: Skin rashes, nausea, vomiting, abdomina...
What is the current status of trial NCT01485055?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2011-12. Estimated completion is 2016-09-26.
What interventions are being tested in trial NCT01485055?
The interventions under investigation include: Infliximab and Basiliximab (DRUG).
Who is sponsoring clinical trial NCT01485055?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
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