Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acut… (NCT03172455) | Clinical Trial Compass
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Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)
Plain-language summary
An Early Access Program for patients with steroid refractory acute GvHD after hematopoietic stem cell transplantation.
This Program is available for female and male who are recipients of allogenic HSCT and who have been newly diagnosed with acute GvHD.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* This program is available for patients who suffer from steroid refractory acute GvHD after HSCT, or for whom, in the opinion of their treating physician, other treatment options or clinical trials in this indication are unsuitable.
* The disease indication for which the participant required HSCT must be in remission
* Acute graft-versus-host disease (aGvHD), including lower GI involvement (modified
* International Bone Marrow Transplant Registry (IBMTR) Severity Stage 1 to 4 \[\>500 mL diarrhea/day\]), with or without other organ system involvement.
* For women of childbearing potential, had a negative serum or urine pregnancy test within 14 days prior to enrolment.
Exclusion Criteria:
* Participant with manifestations of chronic GvHD
* Participant with acute/chronic GvHD overlap syndrome
* Participant whose GvHD developed after donor lymphocyte infusion
* Participant with severe sepsis involving at least 1 organ failure
* Participant who is seropositive or positive in the nucleic acid test for human immunodeficiency virus (HIV)
* Participant with active hepatitis B or C
* If female, participant is pregnant or lactating at the time of enrollment, or has plans to become pregnant during the program
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.