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NCT01954979 · ClinicalTrials.gov registry record · Phase 1
Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD)
A Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT01954979 is a Phase 1 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 56 participants.
The verdict
NCT01954979, a Phase 1 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
The participant is invited to take part in this study because they have chronic Graft versus Host Disease (cGVHD) that is not responding to standard treatment with steroids. This research study is a way of gaining new knowledge about the treatment of patients with cGVHD. This research study is evaluating a drug called abatacept. Abatacept is a drug that alters and suppresses the immune system. Abatacept is approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe active rheumatoid arthritis in adults and of severe juvenile idiopathic arthritis (JIA) in patients who have failed prior therapy with disease-modifying anti-rheumatic drugs (DMARDs). These are autoimmune conditions, ie caused by an overactive immune system that attacks normal tissues and organs. It is currently being tested in a variety of other autoimmune conditions. In this case it is considered experimental. cGVHD is caused by the donor cells attacking various organs of the recipient. The investigators try to minimize this immune attack by using corticosteroids such as prednisone. In severe cases prednisone is not sufficient and other immunosuppressive medications are used in addition in order to more efficiently control cGVHD and to limit the dose and consequently the multiple side-effects of corticosteroids. This study is being done to determine if the use of abatacept is safe in patients with cGVHD and if it can facilitate a better control of cGVHD. During this study the participants will be evaluated for side effects from the treatment with abatacept, and for response of the cGVHD to the treatment. There will be two groups of participants in the study. The first group will be treated at a relatively low dose of abatacept. If this is found to be safe then the second group will be treated at a higher dose. Three to four tablespoons of blood will be drawn at every 2 week visit in order to determine your blood counts, kidney and liver function. Some of the blood will
Interventions
- DRUG Abatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2014-03-27 |
| Est. Completion | 2024-01-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01954979
The ClinicalTrials.gov registry entry for NCT01954979 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Abatacept is the first listed.
NCT01954979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01954979 about?
NCT01954979 is a clinical study titled "Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD)". The participant is invited to take part in this study because they have chronic Graft versus Host Disease (cGVHD) that is not responding to standard treatment with steroids. This research study is a way of gaining new knowledge about the treatment of patients with cGVHD. This research study is evalu...
What is the current status of trial NCT01954979?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2014-03-27. Estimated completion is 2024-01-16.
What interventions are being tested in trial NCT01954979?
The interventions under investigation include: Abatacept (DRUG).
Who is sponsoring clinical trial NCT01954979?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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