Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)
1 other identifier
expanded_access
N/A
0 countries
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Brief 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.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2017
CompletedFirst Posted
Study publicly available on registry
June 1, 2017
CompletedOctober 5, 2020
September 1, 2020
May 29, 2017
September 30, 2020
Conditions
Interventions
Application 90 mg/kg loading dose day 1, 30 mg/kg every other day (day 3 - day 15)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Impatients N.V. trading as myTomorrowslead
- Kamada, Ltd.collaborator
Related Publications (4)
Breit SN, Wakefield D, Robinson JP, Luckhurst E, Clark P, Penny R. The role of alpha 1-antitrypsin deficiency in the pathogenesis of immune disorders. Clin Immunol Immunopathol. 1985 Jun;35(3):363-80. doi: 10.1016/0090-1229(85)90097-2.
PMID: 3886224BACKGROUNDToldo S, Seropian IM, Mezzaroma E, Van Tassell BW, Salloum FN, Lewis EC, Voelkel N, Dinarello CA, Abbate A. Alpha-1 antitrypsin inhibits caspase-1 and protects from acute myocardial ischemia-reperfusion injury. J Mol Cell Cardiol. 2011 Aug;51(2):244-51. doi: 10.1016/j.yjmcc.2011.05.003. Epub 2011 May 12.
PMID: 21600901BACKGROUNDLewis EC, Mizrahi M, Toledano M, Defelice N, Wright JL, Churg A, Shapiro L, Dinarello CA. alpha1-Antitrypsin monotherapy induces immune tolerance during islet allograft transplantation in mice. Proc Natl Acad Sci U S A. 2008 Oct 21;105(42):16236-41. doi: 10.1073/pnas.0807627105. Epub 2008 Oct 13.
PMID: 18852465BACKGROUNDChurg A, Dai J, Zay K, Karsan A, Hendricks R, Yee C, Martin R, MacKenzie R, Xie C, Zhang L, Shapiro S, Wright JL. Alpha-1-antitrypsin and a broad spectrum metalloprotease inhibitor, RS113456, have similar acute anti-inflammatory effects. Lab Invest. 2001 Aug;81(8):1119-31. doi: 10.1038/labinvest.3780324.
PMID: 11502863BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2017
First Posted
June 1, 2017
Last Updated
October 5, 2020
Record last verified: 2020-09