Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acut… (NCT03172455) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
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
SexALL
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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