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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: Clinical Trial Phase 2 study, sponsored by Nationwide Children's Hospital.
NCT01485055 is a Phase 2 study that was terminated before completion, run by Nationwide Children's Hospital. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Complete response was defined as complete resolution of all signs and symptoms of GvHD in all organs using the Modified Glucksberg grading of acute graft versus host disease scale. The score used for GvHD grading complete response was "0" in all evaluable organs.
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 |
Why NCT01485055 stopped before completion
NCT01485055 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Infliximab and Basiliximab is the first listed.
NCT01485055 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01485055's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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