Clinical Trials Logo
  1. Home
  2. Graft vs Host Disease
  3. NCT03172455

Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)

Graft Vs Host Disease Clinical Trial

Official title:
Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)

Clinical Trial 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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03172455
Study type Expanded Access
Source Impatients N.V. trading as myTomorrows
Contact
Status No longer available
Phase
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06080490 - Tacrolimus Blood Concentration and Transplant-related Outcomes in Pediatric HSCT Recipients
Completed NCT00001637 - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults Phase 2
Withdrawn NCT04728646 - Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes Phase 4
Suspended NCT01972438 - A Randomized, Controlled, Double-masked, Clinical Trial of Autologous Serum Eye Drops for Severe Ocular Chronic Graft-versus-host Disease (GVHD) in Hematopoietic Stem Cell Transplant (HSCT) Patients Phase 1/Phase 2
Completed NCT01221766 - Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease N/A
Recruiting NCT01764100 - Mesenchymal Stromal Cells (MSCs) for the Treatment of Graft Versus Host Disease (GVHD) Phase 1
Completed NCT00760981 - A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease Phase 1
Terminated NCT00298324 - Myfortic - Treatment for Extensive cGvHD Phase 3
Completed NCT00224874 - Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302) Phase 2
Completed NCT00023491 - Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells N/A
Completed NCT00023530 - Blood and Marrow Transplant Clinical Research Network N/A
Recruiting NCT05111834 - IRENE-G Study: Impact of Resistance Exercise and Nutritional Endorsement on GvHD Symptoms N/A
Completed NCT02841995 - A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease Phase 2
Recruiting NCT06143501 - Alterations in Intestinal Microbiota, Metabolites, and Immune Cells in Allo-HSCT
Recruiting NCT04622956 - GVHD Prophylaxis With Methotrexate in Haploidentical HCT Using Posttransplant Cyclophosphamide Phase 1/Phase 2
Recruiting NCT03340155 - Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases N/A
Recruiting NCT03836690 - Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation Phase 1
Not yet recruiting NCT06450925 - Vitamin A Supplementation in Allogeneic Stem Cell Transplantation. N/A
Not yet recruiting NCT02506231 - The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome Phase 2/Phase 3
Recruiting NCT01042509 - Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease N/A