Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)
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|ClinicalTrials.gov Identifier: NCT03172455|
Expanded Access Status : Available
First Posted : June 1, 2017
Last Update Posted : June 1, 2017
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.
Alpha 1 antitrypsin is being tested in a Phase 2/3 Clinical Study to evaluate the safety and efficacy of Glassia (1-4) as an add-on bio pharmacotherapy to conventional steroid treatment in subjects with acute graft versus host disease with lower gastrointestinal involvement (NCT02956122).
|Condition or disease||Intervention/treatment|
|SR aGvHD Acute-graft-versus-host Disease Steroid Refractory Acute Graft Versus Host Disease Graft-versus-host-disease Graft Vs Host Disease Alpha 1-Antitrypsin Deficiency Alpha-1 Proteinase Inhibitor Alpha-1 Protease Inhibitor Deficiency Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant||Drug: Glassia|
GLASSIA (human alpha-1 proteinase inhibitor (A1PI), also known as human alpha-1 antitrypsin, Kamada-AAT or Kamada-API) is a, liquid, ready-to-use preparation of human A1PI. Alpha-1 proteinase inhibitor belongs to the family of serine proteinase inhibitors and is primarily produced in the liver and secreted into the circulation. In addition to its anti-proteinase activity, A1PI showed to have anti-inflammatory, anti-apoptotic and immunomodulatory properties (1-4).
GLASSIA is an injection solution prepared from human plasma collected from healthy volunteer blood donors in accordance with Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations. GLASSIA was approved in the United States (US) in July 2010 and is indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency).
|Study Type :||Expanded Access|
|Official Title:||Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)|
- Drug: Glassia
Application 90 mg/kg loading dose day 1, 30 mg/kg every other day (day 3 to day 15), once weekly 120 mg/kg from day 15 to day 50Other Name: Alpha 1 antitrypsin
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172455
|Contact: Michel van Harten, MD||+31 email@example.com|
|Contact: Alice Cardoso, MSc||+31 firstname.lastname@example.org|